Regional Regulatory Affairs

6 days ago

Singapore INTEGRITY PARTNERS PTE. LTD. Full time

**Job Position Summary**:

- **Regulatory Strategy & Line management**:

- **Regional position in MNC**:

- **Medical Devices - Low to High Risk Class**

**Main Responsibilites**:

- Manage the submission of documents and handle inquiries from regulatory authorities in assigned regions.
- Develop and execute effective strategies for securing regulatory approvals
- Enhance regulatory processes and implement a system for managing regulatory information.
- Support regulatory aspects during due diligence processes and stay updated on new regulations.
- Analyze regulatory data to gain competitive insights.
- Foster collaboration among departments, providing regulatory expertise and leading regional projects.
- Act as the primary internal regulatory/quality contact, assisting in-country teams and distributors.
- Handle post-marketing quality issues e.g. product complaints/recalls, audits, coordinating FSCA, QMS management and regulatory reporting.

**Application Requirements**:

- Minimum of **5 - 8 years' experience **in regional regulatory affairs in **medical devices **or **IVD **.
- Bachelor's degree in Pharmacy, Life Sciences, or a related scientific field.
- Thorough familiarity with the global regulatory landscape.
- Strong multitasking and project management skills, coupled with effective communication and collaboration abilities.
- Experience with leading at least 1 other executive will be advantageous.

**Interested Applicants**:
**Not the right opportunity?**:
We're always looking out for the best talents in the life science industry. If you are currently seeking exciting opportunities within the pharmaceuticals, medical devices, in-vitro diagnostics (IVD), or consumer health industry, do reach out for a confidential chat.

Principal Consultant: Cheong Yee Yin | Registration Number: R22108633 | EA License Number: 17C8502

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