Regulatory Affairs Officer
Remote · Edinburgh, Scotland, United Kingdom or New York City, New York, United States
Job Summary
The Regulatory Affairs Officer at AliveDx will be responsible for building regulatory strategy, determining regulatory requirements, and managing product license registrations with regulatory authorities worldwide. Key responsibilities include advising team members on license application documents, preparing regulatory submissions for various regions, and ensuring compliance with relevant regulations, including ISO13485 and FDA standards. The ideal candidate will have a relevant degree or work experience in a regulatory affairs environment, with skills in communication, collaboration, and attention to detail.
Required Qualifications
- A relevant degree and/or relevant work experience in a regulatory affairs environment
- Great attention to detail, communication and collaboration skills
Desired Qualifications
- Experience in medical device/IVD/Biotech industry
- Experienced in meeting with, making presentations to, and negotiating with regulators
- Previous experience preparing and submitting BLA, 510(k), PMA, CE mark and technical files to other worldwide regulatory authorities
Additional Requirements
- All qualified individuals regardless of nationality, sex, disability, region/belief, sexual orientation or age
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.