Regulatory Affairs Specialist

Job Title Regulatory Affairs Specialist

Develop global regulatory strategies for software medical devices ensuring ongoing compliance throughout the product lifecycle.

Prepare and manage regulatory submissions and approvals in the US, Europe, and Canada.

Represent Regulatory Affairs on cross-functional teams, providing guidance to support product development, audits, and market releases.

Coordinating all activities related to regulatory submissions and approval for software medical devices

Prepare, coordinate, and file regulatory submission documents for the US, Europe, and Canada

Support in creating regulatory submission planning globally

Communicating successful registration/regulatory approval to Business for commercial release

Maintaining existing regulatory filings/ licenses and managing updates

Support internal and external audits

Complying with company policies and guidelines

Bachelor degree in biological sciences, biomedical engineering or equivalent

3-5 years work experience, at least 1 year of which is in the medical device industry

Ability to review and provide critical feedback on design documentation

Ability to communicate and interact with regulatory agencies and consultants

A thorough understanding ISO 13485, IEC 62304, and ISO 14971

Familiarity with the EU Medical Device Directive MDD and Medical Device Regulation MDR

Ability to communicate effectively with QA/RA, R&D, Clinical Science and Marketing teams

Good communication skills, written and verbal

Proficiency in Microsoft Office applications, including Copilot

Regulatory Affairs Certification (preferred)

We believe that we are better together than apart. For this role, this means working in-person at least 3 days per week.

Compensation & benefits Doing meaningful work should come with fair, transparent rewards. The base salary range for this role is €48,611 –€81,018. We determine pay within the range using objective factors, like the skills the role requires, your relevant experience and the responsibility you'll have in this role, alongside internal equity and local market considerations. This role is eligible for 3% annual bonus, with your rewards linked to your performance and company results. We’ll share the full approach with you during the interview process, so you can make a clear, informed decision.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.