Ambu is looking for a Regulatory Affairs Specialist to obtain establishment and product registration approvals in target markets to ensure license to sell. You will provide essential support for regulatory functions.

What You'll Do

Prepare, update, and maintain regulatory documentation to support global submissions, including FDA device listings, Health Canada Medical Device Licenses, EU technical documentation, and other market registrations.
Review and approve product labeling, CERs, PMS Plans, PSURs, packaging, and Instructions for Use (IFUs) for regulatory compliance across key markets.
Maintain regulatory databases such as FDA FURLS/GUDID, Health Canada listings, and EUDAMED, ensuring timely and accurate updates.
Support change control and product lifecycle management activities by providing regulatory impact assessments and guidance.
Maintain organized and inspection-ready regulatory files, correspondence, and submission archives.
Collaborate with Quality, R&D, Marketing, and Supply Chain to ensure regulatory alignment on product changes, risk documentation, and labeling content.

What We're Looking For

Bachelor’s degree in Life Sciences, or a related technical discipline required.
Minimum 3 years of experience in regulatory affairs within the medical device industry or related industry, with direct involvement in U.S. FDA, Health Canada, and EU regulatory submissions and maintenance activities.
Proven experience reviewing and approving labeling, packaging, and Instructions for Use (IFUs).
Proficiency with regulatory and document management systems (e.g., Agile, or equivalent) and regulatory authority portals.
Comprehensive understanding of global medical device regulatory frameworks and relevant ISO standards.
Must be able to read, write and understand English.

Nice to Have

Experience contributing to 510k FDA submissions preferred.
Familiarity with CERs, PSURs, MDRs, and risk management activities preferred.

Technical Stack

Regulatory and document management systems (e.g., Agile)
FDA FURLS/GUDID
Health Canada listings
EUDAMED

Team & Environment

You will collaborate with Quality, R&D, Marketing, and Supply Chain teams.

Work Mode

This position is onsite.

Ambu provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.