575 Customs Regulations jobs in Singapore
Lead Import & Export Executive (US Customs Regulations / North)
Posted today
Job Viewed
Job Description
Well Established Network Provider Company
Salary Range: $3000 - $4000 + AWS
Performance Bonus and Attendance Bonus provided
Working days & hours: 9:00AM – 6:00PM (Monday – Friday)
Working Location at Ang Mo Kio
Excellent Welfare & Benefits
Job Scope
Manage full set of import/export & transshipment documents (invoices, packing list, permits, declarations).
Handle TradeNet permit applications, amendments, cancellations, and refunds.
Ensure compliance with controlled/prohibited/dutiable items regulations.
Apply correct HS codes, duty/tax calculations, and valuation methods (WTO, Incoterms).
Process Certificates of Origin (COO), Rules of Origin (ROO), and Free Trade Agreement (FTA) applications.
Manage temporary import/export procedures (ATA Carnets, duty/GST relief)
Liaise with freight forwarders, 3PLs, shipping lines, suppliers, and internal teams to ensure timely clearance and delivery.
Maintain shipment records and support audits with accurate customs documentation.
Requirement
Diploma in Supply Chain Management or equivalent
2 - 3 years related experience in relevant position
Possess a valid Customs Declarant Certificate is an advantage.
Candidates are encouraged to apply this position via Apply Now button with the following information in the resume:
Work experiences and job responsibilities
Current and Expected salary
Reason for leaving
Date of availability
Education background
We regret that only shortlisted candidates will be contacted.
YEOW CHANG FU (R )
EA Recruitment Pte Ltd
EA License No: 21C0492
#J-18808-Ljbffr
Lead Import & Export Executive (US Customs Regulations / North)
Posted 11 days ago
Job Viewed
Job Description
• Well Established Network Provider Company
• Salary Range: $3000 - $4000 + AWS
• Performance Bonus and Attendance Bonus provided
• Working days & hours: 9:00AM – 6:00PM (Monday – Friday)
• Working Location at Ang Mo Kio
• Excellent Welfare & Benefits
Job Scope
- Manage full set of import/export & transshipment documents (invoices, packing list, permits, declarations).
- Handle TradeNet permit applications, amendments, cancellations, and refunds.
- Ensure compliance with controlled/prohibited/dutiable items regulations.
- Apply correct HS codes, duty/tax calculations, and valuation methods (WTO, Incoterms).
- Process Certificates of Origin (COO), Rules of Origin (ROO), and Free Trade Agreement (FTA) applications.
- Manage temporary import/export procedures (ATA Carnets, duty/GST relief)
- Liaise with freight forwarders, 3PLs, shipping lines, suppliers, and internal teams to ensure timely clearance and delivery.
- Maintain shipment records and support audits with accurate customs documentation.
Requirement
- Diploma in Supply Chain Management or equivalent
- 2 - 3 years related experience in relevant position
- Possess a valid Customs Declarant Certificate is an advantage.
Candidates are encouraged to apply this position via Apply Now button with the following information in the resume:
- Work experiences and job responsibilities
- Current and Expected salary
- Reason for leaving
- Date of availability
- Education background
We regret that only shortlisted candidates will be contacted.
YEOW CHANG FU (R )
EA Recruitment Pte Ltd
EA License No: 21C0492
Regulatory Affairs
Posted today
Job Viewed
Job Description
Our client is an exciting American medical devices startup in the field of pregnancy assisted birthing instruments. The company is rapidly expanding its operations here in Singapore and is looking for the position of Regulatory Affairs & QMS Manager. This is a newly created headcount in Singapore.
Regulatory Affairs & QMS Manager.
Reporting to the Chief QARA Officer (Based in Singapore), you will be responsible for:
Regulatory Affairs & Compliance:
- Serve as the Person Responsible for Regulatory Compliance (PRRC) under Article 15 of the EU MDR for full or selected scope of responsibility.
- Interpret and apply global medical device regulations and standards.
- Lead the preparation and submission of regulatory dossiers and product registrations (e.g., CE Mark Technical Documentation, Asia, Middle East, etc.).
- Maintain regulatory intelligence and proactively communicate changes to the organization.
- Collaborate with marketing and commercial teams to ensure labelling, instructions for use (IFU), and advertisements meet internal regulatory and quality requirements.
- Review and approve global marketing and promotional materials to ensure consistency with approved product claims and compliance with regional regulatory requirements (e.g., EU MDR, FDA advertising and promotional guidelines, and other global standards).
Quality Management System (QMS):
- Serve as the QMS Management Representative as required by ISO 13485.
- Maintain and continuously improve the QMS to ensure ongoing compliance with ISO 13485, EU MDR and FDA 21 CFR Part 820.
- Lead internal audits, management reviews, and risk management activities.
- Drive corrective and preventive action (CAPA) systems and support root cause analysis efforts.
- Monitor and report on QMS performance metrics and key quality indicators (KPIs).
- Ensure proper document control and change management processes are implemented.
- Develop, coordinate, and conduct QMS training programs, including onboarding and regular refresher sessions, to ensure employee's understanding and compliance with quality procedures and regulatory requirements.
About the company:
- American startup with senior management team; based in US, Europe and Singapore
- Hybrid work arrangement – 2 days in office, 3 days working from home
- Excellent medical insurance coverage
- Good variable bonus structure
- Great working culture
- Excellent office location (Central – just beside MRT)
Interested applicants, kindly send in a copy of your updated resume in WORD document to stating your current and expected remuneration together with notice period required to current employer.
You can also contact Vincent Low for a confidential discussion at
EA Personnel Registration No: R
Regulatory Affairs
Posted today
Job Viewed
Job Description
The role will be responsible for achieving corporate objectives and effectively ensuring that agreed strategies are implemented. Accountable for all regional and local regulations for the statutory compliance of all regulatory and QA affairs activities of the Company.
A key requirement will be to balance internal hands-on execution priorities with regional strategic alignment, and at the same time, be able to navigate the current complex policy environment.
Contribute with regulatory skills to the innovation of products and services focusing on improving patient's outcome. The role requires strong understanding of the regional business environment, work in collaboration with regulatory/ Q&R team in the markets, strong interaction with corporate/manufacturing RA teams on Regulatory Affairs matters.
To represent Terumo and participate in industry associations (e.g. APACMed, MTAA, etc.) to create Terumo voice of advocacy.
Key Functions/Responsibilities
Strategic Planning:
• Developing and implementing regional regulatory strategies and processes to support the timely registration of new products, major changes and life cycle management.
• Recommend strategies to the business units on ways to resolve issues related to regulatory premarket activities and promote strong partnerships to drive
implementation and resolution.
• Represent Terumo in local or regional standards committees, industry associations, national competent authorities influencing future regulations and standards and deploy them in the organization
• Proactively identify market opportunities by influencing product registration, prioritizing product registration, mitigate potential regulatory approval risks based
on regulations, standards, country-specific issues or other unique characteristics
• Effectively communication between global, TAP RA to ensure implementation of
all strategic plans.
Operation Efficiency:
• Coordinate with Regulatory Affairs in the manufacturing units and CRAO and
regulatory affairs teams in the countries under the scope to ensure optimal,
efficient and compliant registration and QA reporting.
• Lead and drive RA/QA activities in accordance with local and international
requirements to ensure Terumo products are registered on time or life cycle
management in the markets are in scope of responsibility, and post marketing
surveillance risks are minimised.
• Responsible for Regulatory monitoring and analysis of new or updated local
legislation and for assuring in-time registration in the local market (country).
• Create a regulatory plan and a labelling plan (when needed) to ensure
consistency and guidance to the market introduction projects.
• Improve efficiency of entity RA teams to create a cogent process of
documents/data management / storage and / or document flow which is easy and
efficient for access to relevant stakeholders.
• Work with in-country RA teams to ensure product compliance by executing the
annual regulatory plan and reviewing all relevant compliance evidence.
• Consult with product and solutions teams to ensure timely, effective and efficient
transition to new requirements.
• Management of distributors and ensure compliance on RA&QA matters
• Encourage creation and use of automated / visual dashboards and scorecards
for as many business and function process tracks
Talent Development and Management:
• Act as a mentor and supporter to the in-country regulatory affairs team members.
• Share knowledge and guide and mentor others about regulatory best practices
and registration standards for regulatory approvals and post-market needs.
• Work with HR to actively, plan, develop and assess learning needs of key
Associates, with specific focus on current and future business needs of the
organization
• Build a personal network within the relevant talent community and take personal
accountability in attracting, developing, mentoring, retaining and growing best
regulatory affairs talent in the region
• Provide TAP/RA associates with educational programs about RA knowledge enhancement, Terumo group products, and BU marketing strategy.
• Organise yearly Asia RA meeting for development and planning of RA yearly
strategy plans.
Deliver through a hands-on management style:
• Gemba (visiting field or floor), Gembutsu (seeing actual products in R&D,
production and use), and Genjitsu (facing reality) are fundamental Terumo /
Japanese business traits. it is important for this role to demonstrate this.
• Always remain accessible and practice open management. Support teams in
execution of product requirements and registration.
Champion of Terumo culture:
• Work on establishing a close-knit, collaborative and supportive team within the
region. Understand BUs operations and priorities, work cooperatively with others
across the organization to achieve shared objectives to support business
requirements.
• Be a quality champion by viewing each issue from a "Gemba" perspective in order
to find the optimal solution. Pursue excellence in product quality, from product
supply to customer care.
• Focus efforts on continuous improvement; has a knack for identifying and seizing
opportunities for synergy and integration. Figure out the process necessary to get
things done
Education & Experience:
• Graduate or Post Graduate degree/s. (Medical / biomedical background)
• Working experience in Regulatory Affairs Medical Device (class 1, 2 and 3) is a must
• A minimum of 5 years working experience in Regulatory Affairs in APAC Team management experience.
• Proficient in Japanese and ability to transcribe dossier from Japanese to English
Key Technical/Functional Competencies:
• High level of regulatory concepts and standards
• Knowledge of product development and clinical investigation
• Highly regarded personal work ethics and character
• Talent Management. People skills extraordinaire, people empathy & compassion
• Open, inspiring and high quality communication style.
• Willingness to ask for help
• Relevant in-country & sectoral / sub-sectoral understanding (an exception can be made for a highly talented candidate)
Regulatory Affairs
Posted today
Job Viewed
Job Description
Our client is an exciting American medical devices startup in the field of pregnancy assisted birthing instruments. The company is rapidly expanding its operations here in Singapore and is looking for the position of Regulatory Affairs & QMS Manager.
Regulatory Affairs & QMS Manager.
Reporting to the Chief QARA Officer (Based in Singapore), you will be responsible for:
Regulatory Affairs & Compliance:
- Serve as the Person Responsible for Regulatory Compliance (PRRC) under Article 15 of the EU MDR for full or selected scope of responsibility.
- Interpret and apply global medical device regulations and standards.
- Lead the preparation and submission of regulatory dossiers and product registrations (e.g., CE Mark Technical Documentation, Asia, Middle East etc.).
- Maintain regulatory intelligence and proactively communicate changes to the organization.
- Collaborate with marketing and commercial teams to ensure labelling, instructions for use (IFU), and advertisements meet internal regulatory and quality requirements.
- Review and approve global marketing and promotional materials to ensure consistency with approved product claims and compliance with regional regulatory requirements (e.g., EU MDR, FDA advertising and promotional guidelines, and other global standards).
Quality Management System (QMS):
- Serve as the QMS Management Representative as required by ISO 13485.
- Maintain and continuously improve the QMS to ensure ongoing compliance with ISO13485, EU MDR and FDA 21 CFR Part 820.
- Lead internal audits, management reviews, and risk management activities.
- Drive corrective and preventive action (CAPA) systems and support root cause analysis efforts.
- Monitor and report on QMS performance metrics and key quality indicators (KPIs).
- Ensure proper document control and change management processes are implemented.
- Develop, coordinate, and conduct QMS training programs, including onboarding and regular refresher sessions, to ensure employee's understanding and compliance with quality procedures and regulatory requirements.
About the company:
- American startup with senior management team; based in US, Europe and Singapore
- Hybrid work arrangement – 2 days in office, 3 days working from home
- Excellent medical insurance coverage
- Good variable bonus structure
- Great working culture
- Excellent office location (Central – just beside MRT)
Interested applicants, kindly send in a copy of your updated resume in WORD document to stating your current and expected remuneration together with notice period required to current employer.
You can also contact Vincent Low for a confidential discussion at
EA Personnel Registration No: R
Regulatory Affairs
Posted today
Job Viewed
Job Description
Regulatory Affairs & QMS Manager.
Reporting to the Chief QARA Officer (Based in Singapore), you will be responsible for:
Regulatory Affairs & Compliance:
- Serve as the Person Responsible for Regulatory Compliance (PRRC) under Article 15 of the EU MDR for full or selected scope of responsibility.
- Interpret and apply global medical device regulations and standards.
- Lead the preparation and submission of regulatory dossiers and product registrations (e.g., CE Mark Technical Documentation, Asia, Middle East etc.).
- Maintain regulatory intelligence and proactively communicate changes to the organization.
- Collaborate with marketing and commercial teams to ensure labelling, instructions for use (IFU), and advertisements meet internal regulatory and quality requirements.
- Review and approve global marketing and promotional materials to ensure consistency with approved product claims and compliance with regional regulatory requirements (e.g., EU MDR, FDA advertising and promotional guidelines, and other global standards).
- Serve as the QMS Management Representative as required by ISO 13485.
- Maintain and continuously improve the QMS to ensure ongoing compliance with ISO13485, EU MDR and FDA 21 CFR Part 820.
- Lead internal audits, management reviews, and risk management activities.
- Drive corrective and preventive action (CAPA) systems and support root cause analysis efforts.
- Monitor and report on QMS performance metrics and key quality indicators (KPIs).
- Ensure proper document control and change management processes are implemented.
- Develop, coordinate, and conduct QMS training programs, including onboarding and regular refresher sessions, to ensure employee's understanding and compliance with quality procedures and regulatory requirements.
- American startup with senior management team; based in US, Europe and Singapore
- Hybrid work arrangement - 2 days in office, 3 days working from home
- Excellent medical insurance coverage
- Good variable bonus structure
- Great working culture
- Excellent office location (Central - just beside MRT)
You can also contact Vincent Low for a confidential discussion at .
EA Personnel Registration No: R
Regulatory Affairs
Posted today
Job Viewed
Job Description
A key requirement will be to balance internal hands-on execution priorities with regional strategic alignment, and at the same time, be able to navigate the current complex policy environment.
Contribute with regulatory skills to the innovation of products and services focusing on improving patient's outcome. The role requires strong understanding of the regional business environment, work in collaboration with regulatory/ Q&R team in the markets, strong interaction with corporate/manufacturing RA teams on Regulatory Affairs matters.
To represent Terumo and participate in industry associations (e.g. APACMed, MTAA, etc.) to create Terumo voice of advocacy.
Key Functions/Responsibilities
Strategic Planning:
• Developing and implementing regional regulatory strategies and processes to support the timely registration of new products, major changes and life cycle management.
• Recommend strategies to the business units on ways to resolve issues related to regulatory premarket activities and promote strong partnerships to drive
implementation and resolution.
• Represent Terumo in local or regional standards committees, industry associations, national competent authorities influencing future regulations and standards and deploy them in the organization
• Proactively identify market opportunities by influencing product registration, prioritizing product registration, mitigate potential regulatory approval risks based
on regulations, standards, country-specific issues or other unique characteristics
• Effectively communication between global, TAP RA to ensure implementation of
all strategic plans.
Operation Efficiency:
• Coordinate with Regulatory Affairs in the manufacturing units and CRAO and
regulatory affairs teams in the countries under the scope to ensure optimal,
efficient and compliant registration and QA reporting.
• Lead and drive RA/QA activities in accordance with local and international
requirements to ensure Terumo products are registered on time or life cycle
management in the markets are in scope of responsibility, and post marketing
surveillance risks are minimised.
• Responsible for Regulatory monitoring and analysis of new or updated local
legislation and for assuring in-time registration in the local market (country).
• Create a regulatory plan and a labelling plan (when needed) to ensure
consistency and guidance to the market introduction projects.
• Improve efficiency of entity RA teams to create a cogent process of
documents/data management / storage and / or document flow which is easy and
efficient for access to relevant stakeholders.
• Work with in-country RA teams to ensure product compliance by executing the
annual regulatory plan and reviewing all relevant compliance evidence.
• Consult with product and solutions teams to ensure timely, effective and efficient
transition to new requirements.
• Management of distributors and ensure compliance on RA&QA matters
• Encourage creation and use of automated / visual dashboards and scorecards
for as many business and function process tracks
Talent Development and Management:
• Act as a mentor and supporter to the in-country regulatory affairs team members.
• Share knowledge and guide and mentor others about regulatory best practices
and registration standards for regulatory approvals and post-market needs.
• Work with HR to actively, plan, develop and assess learning needs of key
Associates, with specific focus on current and future business needs of the
organization
• Build a personal network within the relevant talent community and take personal
accountability in attracting, developing, mentoring, retaining and growing best
regulatory affairs talent in the region
• Provide TAP/RA associates with educational programs about RA knowledge enhancement, Terumo group products, and BU marketing strategy.
• Organise yearly Asia RA meeting for development and planning of RA yearly
strategy plans.
Deliver through a hands-on management style:
• Gemba (visiting field or floor), Gembutsu (seeing actual products in R&D,
production and use), and Genjitsu (facing reality) are fundamental Terumo /
Japanese business traits. it is important for this role to demonstrate this.
• Always remain accessible and practice open management. Support teams in
execution of product requirements and registration.
Champion of Terumo culture:
• Work on establishing a close-knit, collaborative and supportive team within the
region. Understand BUs operations and priorities, work cooperatively with others
across the organization to achieve shared objectives to support business
requirements.
• Be a quality champion by viewing each issue from a "Gemba" perspective in order
to find the optimal solution. Pursue excellence in product quality, from product
supply to customer care.
• Focus efforts on continuous improvement; has a knack for identifying and seizing
opportunities for synergy and integration. Figure out the process necessary to get
things done
Education & Experience:
• Graduate or Post Graduate degree/s. (Medical / biomedical background)
• Working experience in Regulatory Affairs Medical Device (class 1, 2 and 3) is a must
• A minimum of 5 years working experience in Regulatory Affairs in APAC Team management experience.
• Proficient in Japanese and ability to transcribe dossier from Japanese to English
Key Technical/Functional Competencies:
• High level of regulatory concepts and standards
• Knowledge of product development and clinical investigation
• Highly regarded personal work ethics and character
• Talent Management. People skills extraordinaire, people empathy & compassion
• Open, inspiring and high quality communication style.
• Willingness to ask for help
• Relevant in-country & sectoral / sub-sectoral understanding (an exception can be made for a highly talented candidate)
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Regulatory Affairs
Posted today
Job Viewed
Job Description
Our client is an exciting American medical devices startup in the field of pregnancy assisted birthing instruments. The company is rapidly expanding its operations here in Singapore and is looking for the position of Regulatory Affairs & QMS Manager.
Regulatory Affairs & QMS Manager.
Reporting to the Chief QARA Officer (Based in Singapore), you will be responsible for:
Regulatory Affairs & Compliance:
- Serve as the Person Responsible for Regulatory Compliance (PRRC) under Article 15 of the EU MDR for full or selected scope of responsibility.
- Interpret and apply global medical device regulations and standards.
- Lead the preparation and submission of regulatory dossiers and product registrations (e.g., CE Mark Technical Documentation, Asia, Middle East etc.).
- Maintain regulatory intelligence and proactively communicate changes to the organization.
- Collaborate with marketing and commercial teams to ensure labelling, instructions for use (IFU), and advertisements meet internal regulatory and quality requirements.
- Review and approve global marketing and promotional materials to ensure consistency with approved product claims and compliance with regional regulatory requirements (e.g., EU MDR, FDA advertising and promotional guidelines, and other global standards).
Quality Management System (QMS):
- Serve as the QMS Management Representative as required by ISO 13485.
- Maintain and continuously improve the QMS to ensure ongoing compliance with ISO13485, EU MDR and FDA 21 CFR Part 820.
- Lead internal audits, management reviews, and risk management activities.
- Drive corrective and preventive action (CAPA) systems and support root cause analysis efforts.
- Monitor and report on QMS performance metrics and key quality indicators (KPIs).
- Ensure proper document control and change management processes are implemented.
- Develop, coordinate, and conduct QMS training programs, including onboarding and regular refresher sessions, to ensure employee's understanding and compliance with quality procedures and regulatory requirements.
About the company:
- American startup with senior management team; based in US, Europe and Singapore
- Hybrid work arrangement – 2 days in office, 3 days working from home
- Excellent medical insurance coverage
- Good variable bonus structure
- Great working culture
- Excellent office location (Central – just beside MRT)
Interested applicants, kindly send in a copy of your updated resume in WORD document to stating your current and expected remuneration together with notice period required to current employer.
You can also contact Vincent Low for a confidential discussion at .
EA Personnel Registration No: R
Tell employers what skills you haveTechnical Documentation
CAPA
FDA
Regulatory Compliance
Quality Management
Change Management
Regulatory Affairs
ISO
Root Cause Analysis
Risk Management
Compliance
Medical Devices
ISO-13485
Audits
EMDR
QMS, Quality Management Systems
Regulatory Requirements
QMS Audit
Regulatory Affairs
Posted today
Job Viewed
Job Description
The role will be responsible for achieving corporate objectives and effectively ensuring that agreed strategies are implemented. Accountable for all regional and local regulations for the statutory compliance of all regulatory and QA affairs activities of the Company.
A key requirement will be to balance internal hands-on execution priorities with regional strategic alignment, and at the same time, be able to navigate the current complex policy environment.
Contribute with regulatory skills to the innovation of products and services focusing on improving patient's outcome. The role requires strong understanding of the regional business environment, work in collaboration with regulatory/ Q&R team in the markets, strong interaction with corporate/manufacturing RA teams on Regulatory Affairs matters.
To represent Terumo and participate in industry associations (e.g. APACMed, MTAA, etc.) to create Terumo voice of advocacy.
Key Functions/Responsibilities
Strategic Planning:
• Developing and implementing regional regulatory strategies and processes to support the timely registration of new products, major changes and life cycle management.
• Recommend strategies to the business units on ways to resolve issues related to regulatory premarket activities and promote strong partnerships to drive
implementation and resolution.
• Represent Terumo in local or regional standards committees, industry associations, national competent authorities influencing future regulations and standards and deploy them in the organization
• Proactively identify market opportunities by influencing product registration, prioritizing product registration, mitigate potential regulatory approval risks based
on regulations, standards, country-specific issues or other unique characteristics
• Effectively communication between global, TAP RA to ensure implementation of
all strategic plans.
Operation Efficiency:
• Coordinate with Regulatory Affairs in the manufacturing units and CRAO and
regulatory affairs teams in the countries under the scope to ensure optimal,
efficient and compliant registration and QA reporting.
• Lead and drive RA/QA activities in accordance with local and international
requirements to ensure Terumo products are registered on time or life cycle
management in the markets are in scope of responsibility, and post marketing
surveillance risks are minimised.
• Responsible for Regulatory monitoring and analysis of new or updated local
legislation and for assuring in-time registration in the local market (country).
• Create a regulatory plan and a labelling plan (when needed) to ensure
consistency and guidance to the market introduction projects.
• Improve efficiency of entity RA teams to create a cogent process of
documents/data management / storage and / or document flow which is easy and
efficient for access to relevant stakeholders.
• Work with in-country RA teams to ensure product compliance by executing the
annual regulatory plan and reviewing all relevant compliance evidence.
• Consult with product and solutions teams to ensure timely, effective and efficient
transition to new requirements.
• Management of distributors and ensure compliance on RA&QA matters
• Encourage creation and use of automated / visual dashboards and scorecards
for as many business and function process tracks
Talent Development and Management:
• Act as a mentor and supporter to the in-country regulatory affairs team members.
• Share knowledge and guide and mentor others about regulatory best practices
and registration standards for regulatory approvals and post-market needs.
• Work with HR to actively, plan, develop and assess learning needs of key
Associates, with specific focus on current and future business needs of the
organization
• Build a personal network within the relevant talent community and take personal
accountability in attracting, developing, mentoring, retaining and growing best
regulatory affairs talent in the region
• Provide TAP/RA associates with educational programs about RA knowledge enhancement, Terumo group products, and BU marketing strategy.
• Organise yearly Asia RA meeting for development and planning of RA yearly
strategy plans.
Deliver through a hands-on management style:
• Gemba (visiting field or floor), Gembutsu (seeing actual products in R&D,
production and use), and Genjitsu (facing reality) are fundamental Terumo /
Japanese business traits. it is important for this role to demonstrate this.
• Always remain accessible and practice open management. Support teams in
execution of product requirements and registration.
Champion of Terumo culture:
• Work on establishing a close-knit, collaborative and supportive team within the
region. Understand BUs operations and priorities, work cooperatively with others
across the organization to achieve shared objectives to support business
requirements.
• Be a quality champion by viewing each issue from a "Gemba" perspective in order
to find the optimal solution. Pursue excellence in product quality, from product
supply to customer care.
• Focus efforts on continuous improvement; has a knack for identifying and seizing
opportunities for synergy and integration. Figure out the process necessary to get
things done
Education & Experience:
• Graduate or Post Graduate degree/s. (Medical / biomedical background)
• Working experience in Regulatory Affairs Medical Device (class 1, 2 and 3) is a must
• A minimum of 5 years working experience in Regulatory Affairs in APAC Team management experience.
• Proficient in Japanese and ability to transcribe dossier from Japanese to English
Key Technical/Functional Competencies:
• High level of regulatory concepts and standards
• Knowledge of product development and clinical investigation
• Highly regarded personal work ethics and character
• Talent Management. People skills extraordinaire, people empathy & compassion
• Open, inspiring and high quality communication style.
• Willingness to ask for help
• Relevant in-country & sectoral / sub-sectoral understanding (an exception can be made for a highly talented candidate)
Mentoring
Talent Management
Strategic Planning
Talent Development
Legislation
Regulatory Affairs
Marketing Strategy
Investigation
Customer Care
Surveillance
Advocacy
Team Management
Evidence
Product Development
Manufacturing
Business Requirements
Regulatory Affairs
Posted today
Job Viewed
Job Description
Regulatory Affairs & QMS Manager.
Reporting to the Chief QARA Officer (Based in Singapore), you will be responsible for:
Regulatory Affairs & Compliance:
- Serve as the Person Responsible for Regulatory Compliance (PRRC) under Article 15 of the EU MDR for full or selected scope of responsibility.
- Interpret and apply global medical device regulations and standards.
- Lead the preparation and submission of regulatory dossiers and product registrations (e.g., CE Mark Technical Documentation, Asia, Middle East etc.).
- Maintain regulatory intelligence and proactively communicate changes to the organization.
- Collaborate with marketing and commercial teams to ensure labelling, instructions for use (IFU), and advertisements meet internal regulatory and quality requirements.
- Review and approve global marketing and promotional materials to ensure consistency with approved product claims and compliance with regional regulatory requirements (e.g., EU MDR, FDA advertising and promotional guidelines, and other global standards).
- Serve as the QMS Management Representative as required by ISO
- Maintain and continuously improve the QMS to ensure ongoing compliance with ISO13485, EU MDR and FDA 21 CFR Part 820.
- Lead internal audits, management reviews, and risk management activities.
- Drive corrective and preventive action (CAPA) systems and support root cause analysis efforts.
- Monitor and report on QMS performance metrics and key quality indicators (KPIs).
- Ensure proper document control and change management processes are implemented.
- Develop, coordinate, and conduct QMS training programs, including onboarding and regular refresher sessions, to ensure employee's understanding and compliance with quality procedures and regulatory requirements.
- American startup with senior management team; based in US, Europe and Singapore
- Hybrid work arrangement - 2 days in office, 3 days working from home
- Excellent medical insurance coverage
- Good variable bonus structure
- Great working culture
- Excellent office location (Central - just beside MRT)
You can also contact Vincent Low for a confidential discussion at .
EA Personnel Registration No: R