Senior regulatory affairs specialist

3 days ago


Singapore Airswift Full time

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. #J-18808-Ljbffr



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