RA Software Lead

Location: Fully Remote (Europe)

Physical Office Hub: Stockholm

Employment Type: Full-time

We are seeking a Lead Regulatory Affairs Specialist with a strong software and engineering focus to support regulatory decision-making across medical devices and clinical software.

This senior individual contributor role combines Regulatory Affairs expertise with deep software understanding, enabling risk-based regulatory judgments in complex, software-heavy medical environments. The role works closely with engineering, product, clinical, and business teams to align regulatory strategy with product development.

What You’ll Do

• Define and support regulatory strategy across medical devices and software portfolios
• Assess whether software qualifies as a medical device
• Make regulatory judgment calls on clinical tools, software interfaces, and standalone software
• Decide what regulatory documentation is required for submissions or internal compliance
• Coach teams on RA requirements, including when software falls outside medical device scope
• Collaborate closely with software developers and QA teams

Required Skills & Experience

• Senior-level experience in Regulatory Affairs for medical devices or medical software
• Strong understanding of software engineering environments
• Experience with EU and/or FDA regulations
• Ability to work independently and cross-functionally

Work Setup

• Fully remote (Europe)
• CET ± UK & Finland time zones
• In-person team meetings in Stockholm every 4–6 weeks
• 40 hours per week

Apply

Apply directly via LinkedIn or send your CV to [email protected]