Regulatory Affairs Specialist | $7k | Healthcare & Medical Devices

• Basic up to $7,000 + Variable Bonus
• Monday – Friday, 8:30am – 6pm
• Location: Queenstown

Responsibilities

1. Draft, compile, and maintain technical documents to meet domestic and international regulations, particularly EU MDR 2017/745.
2. Prepare and submit regulatory documents for new registrations, renewals, and change notifications (e.g., US FDA, SG HSA, AUS TGA).
3. Ensure compliance with regulatory requirements and standards for medical devices.
4. Collaborate with internal teams for documentation and information gathering.
5. Liaise with regulatory authorities and representatives to facilitate product approval and address any deficiencies or queries.
6. Support adverse event reporting and notify regulatory authorities within required timelines.
7. Participate in internal and external audits, including supplier audits.
8. Keep updated on regulatory requirements and changes.
9. Ensure compliance with post-market surveillance regulations.

Requirements

1. Min. Degree in biological sciences, bioengineering, pharmacy, or a related field.
2. 4–5 years of experience in medical device regulatory affairs, with expertise in FDA 510(k) submissions or CE marking.
3. Knowledgeable in regulatory guidelines and standards such as ISO 13485 and EU MDR 2017/745.
4. Ability to work both independently and collaboratively.
5. Strong analytical, organisational and problem-solving abilities.
6. Excellent written and verbal communication skills.

For consideration, kindly submit your CV by clicking “APPLY NOW” or email to mtc095@mtcconsulting.com.sg.

Only shortlisted candidates would be notified.

MTC Consulting Pte Ltd | 15C7752
EA. Registration No.: R24123733 | Chen Yit Keat