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
Interested candidates should submit an updated resume that highlights relevant experience and qualifications.
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
