1,117 Regulatory Standards jobs in Singapore

Basic Functions:

• Oversee the quality assurance program to ensure product quality and compliance.
• Implement and maintain the Quality Management System (QMS).
• Manage worldwide product registration, licensing, and regulatory compliance.

Key Responsibilities:

• Ensure proper implementation and maintenance of QMS and Quality Control procedures.
• Provide direction on quality matters, ensuring compliance with regulatory requirements.
• Maintain document control for product specifications, manuals, and quality records.
• Oversee product and process validation to demonstrate compliance and capability.
• Ensure effective implementation of corrective actions for quality issues.
• Conduct quality system reviews to maintain compliance with required standards.
• Manage regulatory documentation for worldwide product registration, including US FDA, CE marking, and IVD regulations.
• Identify training needs, set department objectives, and oversee staff responsibilities.
• Approve Certificates of Analysis and Certificates of Origin.

Requirements:

• Bachelor's degree in Biotechnology, Biology, Biomedical Sciences, or a related scientific discipline, or an equivalent qualification.
• Preferably 5 years of experience in Quality Assurance, Regulatory Affairs, and Compliance within the biomedical, in-vitro diagnostics, medical devices or related industry.
• Strong expertise in QMS, ISO standards, GMP, MDSAP, and global regulatory frameworks.
• Proficiency in regulatory documentation and compliance processes.
• Strong analytical skills with the ability to collaborate across teams and regulatory bodies.

Responsibilities

1. Product Registration

• Manage the process of registration and regulatory approvals for new products, change notification of products and special authorisation route, ensuring all regulatory compliance, submission.
• Handle the maintenance and renewal of Product Registration License for Singapore and/or various countries, ensuring adherence to the country specific requirements.
• Maintain the records in the system on Letter of Authorisation (LOA) for sales issued by manufacturers, providing the BU Manager a platform to track and take necessary action
• Conduct assessment on risk class, grouping of the products and marketing history for new products.
• Conduct assessment when there are changes to the existing products, communicating the changes to the authorities (HSA), and document/communicate the approval internally to Operations and Sales.
• Keep abreast of the new regulatory requirements both in Singapore and/or other countries in the region.

2. Quality Management

• Serve as quality management representative for the company and liaison contact with authorities (HSA) on quality issues as necessary, which include reporting adverse events/product complaint/FSCA to the local authorities.
• Responsible for Quality system documentation and quality approval process including maintenance of accurate and complete records and files.
• Conduct half-yearly GDMPDS/Quality training for existing staff, new staff and whenever there are new updates.
• Develop, revise and review SOPs, Quality Forms and Records when necessary to ensure up-to-date and good standards are maintained, as well as in compliance with the regulatory requirements.
• Communicate and train Operations and Sales on the SOPs and quality standards.
• Collaborate across functionally with various Business Units and external authorities or stakeholders for contribution to the completion of regulatory submissions and reporting.
• Serve as main point of contact for the manufacturers for product compliance process such as product recalls, safety corrections, product complaints; and co-ordinate with Operations to conduct the traceability of sales, customers etc.
• Maintain compliance to GDPMDS (SS620) standard & requirements.

3. Audit & Others

• Participate in Quality System Audits by internal and external auditors.
• Conduct post audit management review on the audit results and the necessary follow up actions
• Handle the yearly GDPMDS (SS620) audit for Asia and Singapore
• Participate and handle quality system audits by supplier/manufacturers as and when required.
• Handle all related licensing & permits eg IMDA, NEA, intercompany agreements and related business licensing
• Execute ad-hoc relevant projects

Requirements

• Degree, preferably in Science discipline
• Relevant background and knowledge in quality management system/regulatory affair and requirements relating to medical devices

We regret to inform that only shortlisted candidates will be contacted.

Responsibilities

1. Product Registration

• Manage the process of registration and regulatory approvals for new products, change notification of products and special authorisation route, ensuring all regulatory compliance, submission.
• Handle the maintenance and renewal of Product Registration License for Singapore and/or various countries, ensuring adherence to the country specific requirements.
• Maintain the records in the system on Letter of Authorisation (LOA) for sales issued by manufacturers, providing the BU Manager a platform to track and take necessary action
• Conduct assessment on risk class, grouping of the products and marketing history for new products.
• Conduct assessment when there are changes to the existing products, communicating the changes to the authorities (HSA), and document/communicate the approval internally to Operations and Sales.
• Keep abreast of the new regulatory requirements both in Singapore and/or other countries in the region.

2. Quality Management

• Serve as quality management representative for the company and liaison contact with authorities (HSA) on quality issues as necessary, which include reporting adverse events/product complaint/FSCA to the local authorities.
• Responsible for Quality system documentation and quality approval process including maintenance of accurate and complete records and files.
• Conduct half-yearly GDMPDS/Quality training for existing staff, new staff and whenever there are new updates.
• Develop, revise and review SOPs, Quality Forms and Records when necessary to ensure up-to-date and good standards are maintained, as well as in compliance with the regulatory requirements.
• Communicate and train Operations and Sales on the SOPs and quality standards.
• Collaborate across functionally with various Business Units and external authorities or stakeholders for contribution to the completion of regulatory submissions and reporting.
• Serve as main point of contact for the manufacturers for product compliance process such as product recalls, safety corrections, product complaints; and co-ordinate with Operations to conduct the traceability of sales, customers etc.
• Maintain compliance to GDPMDS (SS620) standard & requirements.

3. Audit & Others

• Participate in Quality System Audits by internal and external auditors.
• Conduct post audit management review on the audit results and the necessary follow up actions
• Handle the yearly GDPMDS (SS620) audit for Asia and Singapore
• Participate and handle quality system audits by supplier/manufacturers as and when required.
• Handle all related licensing & permits eg IMDA, NEA, intercompany agreements and related business licensing
• Execute ad-hoc relevant projects

Requirements

• Degree, preferably in Science discipline
• Relevant background and knowledge in quality management system/regulatory affair and requirements relating to medical devices

We regret to inform that only shortlisted candidates will be contacted.

Quality Assurance (QA) Officer – Contract

Location: East/Changi Business Park

Monthly Salary: S$2,600.00 per month

Contract Duration: Until end-February

About the Role

We are looking for a QA Officer to support MasterCard operations by assisting Follow-Up Officers with credit card application processes and quality assurance tasks. This role requires someone who is meticulous, organized, and has prior administrative experience.

Responsibilities

• Support Follow-Up Officers with day-to-day operations.
• Conduct call reviews and provide feedback where necessary.
• Ensure turnaround times for product applications are met.
• Maintain and update application records and entries accurately.
• Ensure compliance with operational and service quality standards.

Requirements

• Some prior administrative experience preferred.
• Meticulous and able to work well under pressure.
• Strong organizational skills, with ability to work independently.

How to Apply: Interested applicants, please click on the "Apply Now" to submit your updated resume.  

Please note: Due to the anticipated high volume of applications, only shortlisted candidates will be contacted. All information provided will be treated with strict confidentiality and used solely for recruitment purposes.

Ahmad Ilyas bin Azhari

Consultant – IT & Digital

EA Personnel No: R

Peoplebank Singapore Pte Ltd | EA Licence No: 08C5248

Responsibilities:

• Oversee In-Process QC and Outgoing QC.
• Validation of samples to meet customer requirements.
• Analyse to make quantitative conclusions in respect to the product quality.
• Conduct investigations and ensure CAPA findings, risks, recommendations, Non-conformance's reporting, and outcomes are appropriate and are clearly documented and communicated.
• Work with stakeholders to devise effective, corrective and preventive actions.
• Co-ordinate proficient Corrective reply in 8-Discipline format.
• Compile Weekly / Monthly quality performance reports.
• Coordinate Customer and certification audits.
• Support continues improvement initiatives.
• Perform other duties/projects as required or assigned by superior from time to time.

Requirements:

• Minimum Degree in any Engineering discipline or equivalent.
• Minimum 2-5 years of relevant experience in a precision manufacturing environment.
• Semiconductor working experience preferred.
• Possess knowledge of Quality tools and Quality concept fundamentals.
• Able to perform root cause analysis, process optimization, data analysis and validation effectively manage a high-volume manufacturing setting/environment.
• Ability to apply problem-solving techniques and provide solutions independently.
• Experience on ISO13485 and IATF16949 would be added advantage.

• MNC
• Basic $4500 - $5800 + AWS + Variable Bonus
• Excellent Welfare and Benefits + Career progression
• Working location : Jurong Island (Transport Provided)
• Working days : Monday to Friday
• Working hours : 8am to 4.30pm

Job Responsibilities:

• Manage and maintain the EVAL quality management system compliance with designated management standards that include ISO , ISO and IATF14969
• Report the status of the EVAL quality management system to site leadership periodically
• Management of the EVAL corrective action request system to improve quality performance and ensure compliance with ISO9001, ISO14001 and IATF14969
• Schedule, manage and assist the internal audit program and third-party certification audits
• Maintain all documentation for the Quality Management System
• Manage timely response to customer quality management system questionnaires
• Facilitate formal Root Cause Analysis of quality and other incidents periodically
• Coordinate the corrective action request system to improve quality performance and ensure compliance with quality standards, customers, and organization's QMS
• To perform any other duties or assignments as assigned by superiors

Requirements:

• Bachelor's degree in Engineering
• Minimum of 3 years of relevant experience in a manufacturing environment and quality assurance activities (Audits, CARs, RCA)
• Excellent working knowledge of relevant quality management standards (ISO9001, ISO14001, IATF16949) and related management systems

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.

THIEN CHING MEI (R

EA Recruitment Pte Ltd

EA License No: 21C0492

About Us

That's Electroplating Pte Ltd is Singapore's market leader in electroplating services, specializing in bright tin, matte tin, nickel coating, and electroless nickel plating. Since 1987, we have built a reputation for precision, quality, and responsible operations, serving clients in semiconductor, aerospace, biomedical, automotive, and other high-precision industries.

We are certified under ISO 9001, ISO 14001, and bizSafe Level 3, reflecting our commitment to excellence, environmental responsibility, and workplace safety.

The Role

We are seeking a dedicated and detail-oriented Quality Assurance (QA) Engineer to join our team. This role is central to ensuring compliance with international standards, maintaining our Quality and Environmental Management Systems, and liaising with both internal stakeholders and customers on quality matters.

You will play a vital role in sustaining certifications, permits, and licenses while ensuring the highest levels of safety, compliance, and quality for our operations.

Key Responsibilities

• Lead and coordinate QC/QA activities, including customer communications on quality matters
• Serve as QMS / EMS Coordinator, updating ISO 9001 & 14001 documents and preparing for annual internal and external audits.
• Manage and renew licenses and permits
• Ensure regulatory complianceby working closely with relevant managers.
  Maintain and update compliance records.

Requirements

• Bachelor's Degree/Diploma in Engineering, Quality Management, or a related field.
• Strong organizational skills with ability to manage multiple regulatory requirements and deadlines.
• Good communication skills to liaise effectively with customers, auditors, contractors, and internal teams.
• Detail-oriented, disciplined, and able to work independently with accountability.

Preferred Qualifications

• Working knowledge of ISO 9001:2015 and ISO 14001:2015 systems.
• Familiarity with Singapore regulations (NEA, PUB, MOM, SCDF) is an advantage.
• 2–3 years' experience in Quality Assurance, Compliance, or related fields is preferred.

What We Offer

• Professional development opportunities to grow in quality, compliance, and operational excellence.
• Exposure to a wide range of compliance, audit, and quality management responsibilities.
• A collaborative and safety-driven work culture where every individual's contribution matters.

Education Level

Currently pursuing a Nitec or Higher Nitec in a relevant engineering course, such as Precision Engineering, Aerospace Machining Technology, or Mechatronics & Robotics

Experience Level

No prior experience required

Skills

Basic understanding of engineering drawings and geometric dimensioning and tolerancing (GD&T) is a plus

A strong interest in hands-on work and attention to detail

Good attitude and willingness to learn from experienced technicians and engineers

Ability to follow instructions and work effectively in a team

Basic computer literacy for data entry and documentation

Key Responsibilities:

• Oversee product assembly and finishing, ensuring defect prevention and continuous quality improvement.
• Plan, design, and document QA/QC processes to maintain smooth operations.
• Ensure all products meet quality standards before delivery.
• Implement and maintain a Quality Assurance system in line with ISO 9001 and the Project Quality Plan.
• Prepare and update Inspection & Test Plans (ITPs) and provide guidance during QA/QC meetings.
• Ensure all work follows the Quality Management Plan, including method statements and checklists.
• Supervise handling, storage, and handover of construction materials.
• Conduct site inspections, prepare reports, and approve inspections in assigned areas.
• Maintain accurate records of inspections and tests.
• Manage the non-conformance control system, including issuing and resolving NCRs.

Qualifications / Requirements:

• Minimum of 2 years of QA/QC experience, with ability to work on-site and in a factory setting.
• Knowledge of prefabricated DfMA (Design for Manufacture and Assembly) processes.
• Familiarity with welding techniques and related testing procedures.
• Knowledge of process-oriented quality approaches, with experience in defect prevention, testing, verification, and continuous quality improvement.