- American Medical Device MNC
- Basic up to $4,500 + Completion bonus
- Conversion to permanent role opportunity
- Monday – Friday, 9am – 6pm
- Location: Novena
Responsibilities
- Provide regulatory input and guidance on product requirements throughout the lifecycle.
- Coordinate regulatory submission strategies, manage submissions, and ensure timely approvals.
- Oversee post-marketing compliance, including FSCA, product recalls, adverse event reporting, and GMS SS620.
- Review and approve product labelling, promotional materials, and change controls for compliance.
- Stay updated on regulatory changes, assess impacts, and provide training to stakeholders.
- Assist in regulatory inspections, quality audits, and manage post-marketing surveillance activities.
Requirements
- Min. Diploma in life sciences or engineering
- Relevant regulatory and quality assurance experience in medical devices or life sciences technology
- Knowledge of US FDA and EU medical device regulations will be advantageous
- Familiarity with IVD, drug-device/device drug, cosmetics or OTC products
- Good command of spoken and written English
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
