Specialist, Regulatory Affairs

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.

Objective:

Obtain establishment/product registration approval in desired markets to ensure the license to sell. Provide support for regulatory functions.

Responsibilities and Essential Functions:

• 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.
• All other duties as assigned.

Authorities:

N/A

Work Environment:

This is a manufacturing facility and as a result, employees have the potential to be exposed to noise, chemicals, fumes, airborne particles, machinery, vibration or other workplace hazards controlled within compliance of current safety and health standards.

Qualifications:

• 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.
• Experience contributing to 510k FDA submissions preferred.
• Proven experience reviewing and approving labeling, packaging, and Instructions for Use (IFUs).
• Familiarity with CERs, PSURs, MDRs, and risk management activities preferred.
• 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.