97 Regulatory Affairs Specialists jobs in Singapore

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

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)

• Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
• Oversee documentation efforts to ensure compliance with local and international regulations and standards. Develop and maintain standard operating procedures.
• Develop regulatory strategies and implementation plans for the preparation and submission of new products.
• Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
• Review materials such as marketing literature or user manuals to ensure that regulatory requirements are met.
• Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
• Participate in the development or implementation of clinical trial products.
• Investigate product complaints and prepare documentation and submissions to appropriate regulatory authorities.
• Provide responses to regulatory authority regarding product information or issues.
• Review all regulatory authorities' submission materials to ensure timeliness and accuracy.
• Communicate regulatory information to relevant departments and ensure that information is interpreted correctly.

Job Responsibilities

1. Product registration: including preparation of registration dossier, design of performance evaluation study and manage execution and communication with CRO (clinical research organization).
2. Be the subject matter expert on medical devices laws and regulations for product registration in company's regions of interest.
3. Interface the communication with regulatory agencies, e.g. Health Science Authority, Medical Device Authority, Food and Drug Administration, track the progress of product registration, and resolve problems raised by reviewers during the review process.
4. Involve in the process of product testing, clinical verification, data collection and relevant tracking.
5. Submit to agencies scientific special projects on behalf of the company.
6. Establish collaborative and cooperative working relationship with key opinion leaders and the regulatory bodies.
7. Collaborate with cross-functional teams to meet projects goals with overall organizational objectives.
8. Any other ad-hoc duties or projects as required by the management team.

1. A bachelor's degree in in Life Sciences, Pharmacy, or a related field
2. Familiar with ISO13485 quality management system, solid medical device quality management qualifications, including but not limited to Class B, C and D medical devices.
3. Expert in medical device product registration laws and regulations, able to independently draft registration dossier.
4. You shall have complete registration experience of Class B, C and D medical devices.
5. Familiar with in vitro diagnostic products such as lateral flow immunoassay, PCR, Immunoassay etc.
6. Familiar with IVD product development and commercialization life cycle.
7. Systematically project management, good planning, execution and timely communication. Good presentation skills.
8. Enthusiastic, proactive, and down-to-earth work attitude, strong communication & execution ability, results driven, and a team player.
9. Meticulous and strong sense of responsibility; able to handle stress and tight schedule.

A great opportunity to be part of a dynamic and progressive mid-size SME healthcare provider with a regional presence, as MD Pharmaceuticals Pte Ltd continues on its growth and expansion plans in Singapore, Malaysia, Hong Kong, Thailand, Myanmar and other parts of Asia in the coming years.

MD Pharmaceuticals Pte Ltd is now seeking to hire:

• Regulatory Affairs Pharmacist & Products Specialist (Pharmaceuticals products)

Unlike regular one-dimensional Pharmacist roles, the above position will enable the successful candidates to have more exposure to the related fields of Regulatory Affairs, Sales/Marketing & Business Development in the pharmaceutical industry.

The role is also based locally. However, there will be opportunities for overseas exposure and career advancement if the individual can prove himself /herself through solid work performance.

___

Main responsibilities:

• Assist with regulatory affairs and compliance work for the company's operations in Singapore and the Asian region, including dealing with product suppliers and regulatory bodies like HSA
• Actively stay updated and provide guidance on clinical information related to the company's suite of products, comprising both therapeutic drugs and healthcare supplements
• Drive the sales and marketing efforts of our products by gathering market/competitor information & proposing creative and feasible ideas as well as content to grow the sales and market share of our existing products
• Suggest and look into bringing in new potential products based on up-to-date market research and strong clinical evidence
• Gain a holistic understanding of the medical industry through practical sales and marketing outreach to develop the company's existing client base
• Establish sincere and professional relationships with healthcare professionals as well as key opinion leaders in the healthcare industry
• Assist with product trainings and provide related support to the Sales team
• Handle other duties as assigned

Key requirements:

• Must have at least a Bachelor's Degree in Pharmacy/Pharmacology, with a valid Pharmacist License registered under the Singapore Pharmacy Council
• Practical experience in the healthcare industry, including interaction with patients and healthcare professionals, would be beneficial
• Interested in Sales & Marketing/Business Development with an ability to apply clinical knowledge to better achieve sales and marketing outcomes
• Ability to work independently as well as in a team, including across different cultures and functions
• Solid communication skills, especially in both written and oral English. Working language proficiency in Mandarin/Thai would be an additional advantage for work-related translation purposes.
• Strong interpersonal skills, including ability to convince key stakeholders
• Positive, results-driven with a responsible attitude. Having own initiative is important for this role.
• Any Graphics Design skills, together with the knowledge of softwares such as Adobe Illustrator and Photoshop, etc. would be an advantage.

Interested candidates, please submit your updated resume & expected salary to us through the "Apply Now" button.

About ResMed

At ResMed, we pioneer innovative health technologies that transform millions of lives daily. From connected respiratory care to cloud-based software solutions, our devices span the globe and connect patients, providers, and data to improve healthcare outcomes. We are proud to lead in the medical device space, where quality, compliance, and patient trust are at the heart of our innovation.

Regulatory Affairs (RA) at ResMed is central to ensuring timely and compliant access to global markets. We work across more than 140 countries to deliver safe and effective innovations that improve quality of life. With global reach, deep technical knowledge, and strong regulatory partnerships, we lead with integrity and clarity to shape the future of health technology.

Team Overview

Regulatory Product Strategy & Delivery (RPSD) (Singapore).

The Singapore RPSD team leads regulatory strategy and delivery for products where ResMed Singapore is the legal manufacturer. The team supports New Product Introduction (NPI) and Product Lifecycle Engineering (PLE) projects, enabling global submission readiness, risk assessments, and regional collaboration.

As an individual contributor in this team, the Specialist, Regulatory Product Strategy & Delivery – Singapore will partner with cross-functional stakeholders to ensure design, documentation, and change activities meet regulatory expectations across all key markets (e.g., US, EU, APAC, LATAM)

Position Summary

As a Specialist, Regulatory Product Strategy & Delivery – Singapore, you will contribute directly to the successful delivery of regulatory strategy, submission documentation, and change management activities for Singapore-manufactured devices and accessories.

You will represent Regulatory Affairs on cross-functional teams and collaborate with global RA colleagues to ensure alignment, accuracy, and traceability across submissions and product lifecycle updates. This is a critical role in ensuring regulatory quality, efficiency, and global market continuity.

Key Responsibilities

1. Regulatory Strategy & Execution

• Support regulatory strategy development and documentation for NPI and PLE projects led by the Singapore RPSD team.
• Participate in the preparation, review, and submission of global regulatory filings including 510(k), CE MDR, TGA, Health Canada, and regional registrations.
• Contribute to authoring of submission content such as labelling justifications, equivalence arguments, standards declarations, and technical summaries.

2. Product Change Support

• Evaluate the regulatory impact of product and design changes via DCA/CPA frameworks, contributing to global significance assessments and risk mitigation actions.
• Review and update technical file documentation, declarations, and certificates in collaboration with the Regulatory Foundations team.
• Track submission timelines and deliverables using Jira and other RA platforms.

3. Cross-Functional Collaboration

• Represent Regulatory Affairs in cross-functional project teams involving engineering, clinical, quality, labelling, and supply chain.
• Participate in design reviews, change assessments, and internal risk forums as the RA contributor for Singapore-based products.
• Collaborate with Regional RA and global RPSD counterparts to ensure harmonization of documentation and submission approaches.

4. Regulatory Systems & Process Improvement

• Maintain accurate regulatory records and document control through RIMSYS, Confluence, and SharePoint tools.
• Support continuous improvement activities by contributing to template updates, process harmonization, and RA onboarding content.
• Assist in audit readiness activities and postmarket traceability tasks as needed.

5. Other Duties and Requirements

• Perform additional responsibilities as required to support RA and RPSD objectives.
• Contribute to process improvements and special projects across Regulatory Affairs.
• Support inspections, audits, and team collaboration activities.

Qualifications & Experience

Required

• Bachelor's degree in engineering, life sciences, health policy, or a related field.
• 3+ years of experience in Regulatory Affairs or a compliance-related role within a regulated industry (preferably medical devices).
• Familiarity with product development under design control and regulatory frameworks (e.g., ISO 13485, ISO 14971, 21 CFR 820).
• Strong communication, organization, and document review skills.
• Ability to manage multiple priorities, meet deadlines, and operate effectively in a cross-functional team environment.

Preferred

• Experience preparing or contributing to global regulatory submissions (e.g., FDA 510(k), EU MDR, TGA).
• Understanding of Singapore-specific regulatory frameworks and product license processes.
• Familiarity with submission and documentation tools such as Jira, RIMSYS, and Confluence.
• Experience supporting Class II or III medical devices in respiratory or digital health fields.

Who You Are

You are a regulatory problem-solver and proactive collaborator. You bring technical curiosity and process discipline to your work, with a sharp eye for detail and a strong sense of responsibility for quality. Whether it's preparing documentation, clarifying regulatory pathways, or contributing to design decisions—you show up with clarity, consistency, and a drive to improve.

Joining us is more than saying "yes" to making the world a healthier place. It's discovering a career that's challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now

Job title: Regulatory Affairs Specialist

Reference ID: 36639

Our client, a Japanese pharmaceutical company, is currently seeking to hire a Regulatory Affairs Specialist to support operations across Asia and the ASEAN region. The primary responsibilities of this role include coordinating regulatory submissions, supporting strategy development, and monitoring activities across local affiliates.

You will be reporting to the Regulatory Affairs Department in Japan.

【 Responsibilities 】

‐ Handle mainly regulatory operations tasks

- Report directly to the Regulatory Affairs Department in Japan

- Coordinate regulatory submissions (new and variation) across Asia/ASEAN

- Manage regulatory documents and ensure timely submissions

- Develop regulatory strategies with cross-functional teams

- Track and monitor local affiliate regulatory activities

- Identify and resolve regulatory issues proactively

【 What you will receive 】

- AWS

- Variable Bonus (Depends on Company and Individual performance)

- Annual Leave 14 days

- Medical Leave

- Medical Benefits

- Flexible Benefits (S$1500/year)

- WFH: Once a week to be at Office, others day WFH

【Requirements & Preferences】

(Must)

- Diploma in any discipline.

- Minimum 2 years of experience in Regulatory Affairs within Singapore's pharmaceutical industry.

- Proficiency in both written and spoken English is required to liaise with counterparts and handle documentation.

- Proactive, self-motivated, and able to take initiative with high energy levels.

(Advantageous)

- Strong communication and negotiation skills.

- Logical thinking and sound problem-solving capabilities.

- Ability to adapt well to changes and work effectively under pressure.

- Possess regional experience in a large pharmaceutical company is an advantage.

We regret that only shortlisted candidates will be notified.

Registration No.: R Yeo Ker Ling Caroline)

Recruitment Licence: 12C5051

Job Description

Job Scope:

• Cosmetic Notification
• Documentation preparation: Assist in collecting, organizing product information and technical documents required for cosmetic notification.
• Regulatory submission: Support the submission of cosmetic product notifications to relevant regulatory authorities or online portals. Track and update submission status and follow up on pending applications.
• Database Management
• Maintain and update internal databases or trackers for product notifications, approvals, and related correspondence.
• Support Regulatory Compliance Checks
• Conduct first-line marketing claims review in accordance with the acceptable/prohibited claim list published by the authority.
• Cross-functional Coordination
• Liaise with Brand to gather required information related to product notification and marketing claim review.

Qualifications

• Undergraduate or recent graduate in Pharmacy, Chemistry, Life Sciences, or related field.
• Able to commit full time internship from Oct 2025 to Mar 2026
• Detail-oriented, organized, and able to manage multiple tasks.
• Proficient in Excel.
• Good communication skills (written and verbal).

Key Responsibilities:

• Regulatory Submissions & Approvals
• Prepare, compile, and submit product registration dossiers to HSA and other relevant regulatory authorities.
• Maintain up-to-date knowledge of Singapore's Health Sciences Authority (HSA) guidelines, ASEAN Common Technical Dossier (ACTD), and other regional requirements.
• Ensure timely approvals for new product launches, renewals, and variations.
• Compliance & Documentation
• Review product artwork, labels, and promotional materials for compliance with regulatory standards.
• Maintain regulatory databases and ensure that product licenses, certificates, and approvals are current.
• Support internal audits and regulatory inspections (e.g., HSA GMP audits).
• Cross-Department Collaboration
• Work closely with Quality Assurance, R&D, and Production to ensure regulatory compliance throughout the product lifecycle.
• Provide regulatory guidance for new product development and market expansion projects.

Regulatory Intelligence

• Monitor regulatory changes in Singapore and ASEAN markets and communicate impacts to management.
• Support the development of strategies to address new regulations or compliance risks.

Requirements:

• Bachelor's degree in any Pharmacy, Life Sciences, Chemistry, or related discipline.
• 2–4 years of hands-on regulatory affairs experience in a pharmaceutical, nutraceutical, or medical device environment.
• Knowledge of HSA regulations, GMP standards, and ACTD/ACTR formats.
• Strong attention to detail, organizational skills, and ability to handle multiple projects.
• Excellent written and verbal communication skills.
• Exposure to end-to-end regulatory processes in a lean, fast-paced company.
• Opportunity to broaden regional regulatory experience (ASEAN and beyond).
• Career path towards Senior RA Executive / Regulatory Affairs Manager as the company grows.

Employees Benefits:

1. Opportunities for growth and development within the pharmaceutical industry.

1. A supportive work environment with a focus on teamwork and efficiency.

2. Annual Leave (e.g., 13–18 days per year)

3. Medical Leave / hospitalizasation Leave

4. Medical & Dental Coverage

5. Insurance Coverage (e.g. Hospitalization)

6. Annual Bonus

7. Annual Company Dinner or Team Bonding Activities

8. Long Service Award