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.

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.

• Learn more about our business
• Discover our rich and exciting history
• Learn more about our purpose