Senior Regulatory Affairs Specialist

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.

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.