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Medical Device Regulatory jobs in Central Singapore
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- RECRUIT123 PTE. LTD.Singapore
- Working knowledge of Singapore HSA medical device regulations and registration requirements.
- Our clients are leading medical device, diagnostics, and life…
- INTEGRITY PARTNERS PTE. LTD.Outram
- The successful incumbent will manage all local regulatory activities and report to the Regional Manager.
- As the RA Pharmacist, you will ensure existing & new…
- View all INTEGRITY PARTNERS PTE. LTD. jobs - Outram jobs - Regulatory Affairs Specialist jobs in Outram
- Salary Search: Regulatory Affairs Executive [Pharmaceutical salaries in Outram|textlinkEl]
- National Healthcare GroupSingapore
- Vii. Provide training, competency assessment, and supervision of junior medical technologists, medical technologists, and phlebotomists (where applicable).
- PHARMATECH MEDICAL ENTERPRISE PTE. LTD.MacPherson
- Prepares regulatory documents for regional submissions.
- With direction, develop plans for regulatory strategies.
- INTEGRITY PARTNERS PTE. LTD.Outram
- The successful incumbent will manage all local regulatory activities and report to the Regional Manager.
- As the RA Pharmacist, you will ensure existing & new…
- View all INTEGRITY PARTNERS PTE. LTD. jobs - Outram jobs - Regulatory Affairs Specialist jobs in Outram
- Salary Search: Regulatory Affairs Specialist [Pharmaceutical salaries in Outram|textlinkEl]
- Integrated DNA Technologies (IDT)Singapore 048946
- Ensure product quality and compliance by analyzing QC results, maintaining accurate documentation, identifying defects, and releasing product in accordance with…
- Integrated DNA Technologies (IDT)Singapore 048946
- Ensure product quality and compliance by analyzing QC results, maintaining accurate documentation, identifying defects, and releasing product in accordance with…
- RECRUITPEDIA PTE. LTD.Singapore
- Support audits, regulatory inspections, change controls, product registration andcontinuousQMS improvement.
- Perform and supervise microbiological testing,.
- StrykerSingapore 119968
- Experience in the medical device, healthcare, or pharmaceutical industry is preferred.
- Support regulatory reporting activities by providing quality-related…
- MEDIWHALE (APAC) PTE. LTD.Geylang
- Medical device, diagnostics or SaMD studies.
- Working knowledge of FDA requirements for device studies (21 CFR 50, 56 and 812) and the TMF Reference Model.
- EssilorLuxotticaSingapore
- About 5 years of experience in quality and/or regulatory roles, preferably in medical devices, ophthalmic lenses or optical products.
- Merck KGaASingapore
- Good knowledge of evolving medical trends across the JAPAC region and the regulatory and quality frameworks that govern medical affairs activities.
- National Healthcare GroupSingapore
- Equipment and devices comply with regulatory and safety requirements.
- Perform routine cardiovascular tests, including Transthoracic and Transesophageal.
- View all National Healthcare Group jobs - Singapore jobs
- Salary Search: Medical Technologist salaries in Singapore
- See popular questions & answers about National Healthcare Group
View similar jobs with this employerSCALENCE PTE. LTD.Bukit Merah- Knowledge of medical device quality and regulatory requirements in Malaysia.
- Ensure compliance with Singapore HSA medical device regulations.
- I:EMEDICS PTE. LTD.Geylang
- Promote and sell medical products to healthcare professionals across Singapore to achieve sales targets.
- Stay informed on industry trends, regulatory changes,…
- PatsnapSingapore 179435
- Identify high-value life sciences workflows across areas such as clinical development, translational medicine, business development, competitive intelligence…
- View all Patsnap jobs - Downtown Core jobs - Life Science Consultant jobs in Singapore 179435
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Job Post Details
Regulatory Affairs Executive – Medical Devices / IVD
Singapore
$5,000 - $7,000 a month
-
Permanent, Full-time
Regulatory Affairs Executive – Medical Devices / IVD
Job details
$5,000 - $7,000 a month
Permanent, Full-time
Singapore
Full job description
Salary: S$5,000 – S$7,000 per month
Location: Singapore
About the Role
Our clients are leading medical device, diagnostics, and life sciences organizations seeking Regulatory Affairs Executives to support product registrations and regulatory compliance activities across Singapore and the wider ASEAN region.
This role is ideal for regulatory professionals who enjoy navigating evolving healthcare regulations, managing submissions, and partnering with cross-functional teams to bring compliant medical technologies to market.
Key Responsibilities
Prepare, compile, and submit regulatory applications for medical devices and IVD products to the Health Sciences Authority (HSA).
Support product registrations, renewals, change notifications, and regulatory maintenance activities.
Maintain technical documentation and regulatory files in accordance with applicable regulations and ISO 13485 requirements.
Review product labelling, instructions for use, promotional materials, and packaging to ensure regulatory compliance.
Monitor regulatory changes and assess business impact across product portfolios.
Liaise with local authorities, regional regulatory teams, manufacturers, and internal stakeholders on submission requirements and approval processes.
Support post-market surveillance activities, field safety corrective actions, vigilance reporting, and compliance initiatives where required.
Participate in audits, inspections, quality management activities, and regulatory projects.
Maintain accurate regulatory records and submission databases.
Requirements
Bachelor's Degree in Life Sciences, Biomedical Sciences, Pharmacy, Regulatory Affairs, Biotechnology, or a related discipline.
2–5 years of regulatory affairs experience within medical devices, IVD, diagnostics, or healthcare-related industries.
Working knowledge of Singapore HSA medical device regulations and registration requirements.
Familiarity with ASEAN Medical Device Directive (AMDD) and regional regulatory frameworks is advantageous.
Understanding of ISO 13485 and quality management systems.
Experience preparing regulatory submissions and managing product registrations.
Strong attention to detail with excellent documentation and stakeholder management skills.
Ability to work independently while managing multiple projects and deadlines.
Preferred Experience
Medical Devices
In Vitro Diagnostics (IVD)
Diagnostic Equipment
Surgical Devices
Wound Care Products
Healthcare Technologies
Life Sciences Products
What Success Looks Like
You are able to navigate regulatory pathways confidently, maintain compliant product registrations, manage documentation effectively, and work collaboratively with commercial, quality, and technical teams to ensure products remain available to healthcare providers and patients.
Recruit-123 Pte Ltd
EA Licence No.: 25C2810EA
Recruitment Consultant:
Lian Cher Chieh (Steffan)
EA Registration No.: R1217705
Interested applicants are invited to submit their updated resume for a confidential discussion. Only shortlisted candidates will be contacted.
At Recruit123, we specialize in connecting exceptional talent with leading companies in South- East Asia.
Our business methodology is to provide a seamless recruitment process as easy as 1, 2, 3
Location: Singapore
About the Role
Our clients are leading medical device, diagnostics, and life sciences organizations seeking Regulatory Affairs Executives to support product registrations and regulatory compliance activities across Singapore and the wider ASEAN region.
This role is ideal for regulatory professionals who enjoy navigating evolving healthcare regulations, managing submissions, and partnering with cross-functional teams to bring compliant medical technologies to market.
Key Responsibilities
Prepare, compile, and submit regulatory applications for medical devices and IVD products to the Health Sciences Authority (HSA).
Support product registrations, renewals, change notifications, and regulatory maintenance activities.
Maintain technical documentation and regulatory files in accordance with applicable regulations and ISO 13485 requirements.
Review product labelling, instructions for use, promotional materials, and packaging to ensure regulatory compliance.
Monitor regulatory changes and assess business impact across product portfolios.
Liaise with local authorities, regional regulatory teams, manufacturers, and internal stakeholders on submission requirements and approval processes.
Support post-market surveillance activities, field safety corrective actions, vigilance reporting, and compliance initiatives where required.
Participate in audits, inspections, quality management activities, and regulatory projects.
Maintain accurate regulatory records and submission databases.
Requirements
Bachelor's Degree in Life Sciences, Biomedical Sciences, Pharmacy, Regulatory Affairs, Biotechnology, or a related discipline.
2–5 years of regulatory affairs experience within medical devices, IVD, diagnostics, or healthcare-related industries.
Working knowledge of Singapore HSA medical device regulations and registration requirements.
Familiarity with ASEAN Medical Device Directive (AMDD) and regional regulatory frameworks is advantageous.
Understanding of ISO 13485 and quality management systems.
Experience preparing regulatory submissions and managing product registrations.
Strong attention to detail with excellent documentation and stakeholder management skills.
Ability to work independently while managing multiple projects and deadlines.
Preferred Experience
Medical Devices
In Vitro Diagnostics (IVD)
Diagnostic Equipment
Surgical Devices
Wound Care Products
Healthcare Technologies
Life Sciences Products
What Success Looks Like
You are able to navigate regulatory pathways confidently, maintain compliant product registrations, manage documentation effectively, and work collaboratively with commercial, quality, and technical teams to ensure products remain available to healthcare providers and patients.
Recruit-123 Pte Ltd
EA Licence No.: 25C2810EA
Recruitment Consultant:
Lian Cher Chieh (Steffan)
EA Registration No.: R1217705
Interested applicants are invited to submit their updated resume for a confidential discussion. Only shortlisted candidates will be contacted.
At Recruit123, we specialize in connecting exceptional talent with leading companies in South- East Asia.
Our business methodology is to provide a seamless recruitment process as easy as 1, 2, 3
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