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.