- Basic up to $5,500 + Variable Bonus
- Monday – Friday, 8:30am – 6pm
- Location: Queenstown
Responsibilities
- Draft, compile, and maintain technical documents to meet domestic and international regulations, particularly EU MDR 2017/745.
- Prepare and submit regulatory documents for new registrations, renewals, and change notifications (e.g., US FDA, SG HSA, AUS TGA).
- Ensure compliance with regulatory requirements and standards for medical devices.
- Collaborate with internal teams for documentation and information gathering.
- Liaise with regulatory authorities and representatives to facilitate product approval and address any deficiencies or queries.
- Support adverse event reporting and notify regulatory authorities within required timelines.
- Participate in internal and external audits, including supplier audits.
- Keep updated on regulatory requirements and changes.
- Ensure compliance with post-market surveillance regulations.
Requirements
- Min. Degree in biological sciences, bioengineering, pharmacy, or a related field.
- 4–5 years of experience in medical device regulatory affairs, with expertise in FDA 510(k) submissions or CE marking.
- Knowledgeable in regulatory guidelines and standards such as ISO 13485 and EU MDR 2017/745.
- Ability to work both independently and collaboratively.
- Strong analytical, organisational and problem-solving abilities.
- Excellent written and verbal communication skills.
For consideration, kindly submit your CV by clicking “APPLY NOW” or email to [email protected]
**Only shortlisted candidates would be notified**
MTC Consulting Pte Ltd | 15C7752
EA. Registration No.: R24123733 | Chen Yit Keat
