Regional Regulatory Affairs Manager

2 weeks ago


Singapore INTEGRITY PARTNERS PTE. LTD. Full time

**The Role**:
A principal multi-national company specializing in IVD is looking for a Regional Regulatory Affairs Manager to join their team to drive regulatory activities in the APAC.

**Main Responsibilities**:

- Prepare dossiers for product registration submissions for the timely introduction of new products and responsible for supplemental filings for any changes with the relevant regulatory authorities in Singapore and APAC
- Obtaining and/or maintaining related licenses required for regional affiliates and distributors, including monitoring and follow-ups
- Regulatory intelligence monitoring, advisory and knowledge sharing to HQ, regional affiliates and distributors to ensure compliance with government regulatory requirements in APAC
- Providing leadership and support in managing RA team, coaching and providing technical guidance to drive excellence in RA specialists and regional affiliates

**Requirements**:

- Bachelor Degree in Medical Sciences (e.g. Biomedical, Bioengineering, Pharmacy)
- At least 6 years RA experience or science/technical roles in healthcare industry (e.g. R&D. Clinical)
- Experience with IVD is mandatory
- Good understanding to regulatory framework in APAC and
- Knowledge of MDR in countries outside of APAC e.g. USA, EU, Japan etc
- Approximately 20% travelling is required

**Next Steps**:
Principal Consultant: Cheong Yee Yin

Registration Number: R22108633

EA License Number: 17C8502



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