Senior Regulatory Affairs Specialist
(1-Year Contract)
Location: Singapore (On-Site)
We are seeking a Senior Regulatory Affairs Specialist to join a dynamic global healthcare organization specializing in innovative diagnostic solutions. This role focuses on regulatory submissions and license management across high-growth markets in the Asia-Pacific region.
Key Responsibilities:
- Lead regional market expansion projects, including product registrations and renewals.
- Prepare and review labels and submission documents in compliance with in-country regulations.
- Manage timelines, track project progress, and ensure timely delivery of regulatory submissions.
- Collaborate with cross-functional global teams to resolve submission queries.
- Monitor regulatory updates and provide guidance to product development teams.
- Mentor junior associates and drive continuous improvement initiatives.
Requirements:
- Bachelor’s degree in Life Sciences or related fields.
- Minimum 3 years of regulatory experience in the medical device or diagnostic industry, preferably in the Asia-Pacific region.
- Strong written and communication skills, with the ability to work independently.
- Familiarity with MS Office and applications.
Preferred Qualifications:
- Experience in IVD or high risk medical devices
- Background in technical or operational roles in the medical device industry.
This role offers competitive compensation, professional development opportunities, and a collaborative environment committed to improving global health.