Senior Regulatory Affairs Engineer (TCI)

About the Role

Shape the future of medical technology by driving complex regulatory strategies for cutting-edge active medical devices and Software as a Medical Device (SaMD). This is an exciting opportunity to influence product development from research through global market launch in a fast-paced, distributed environment.

Responsibilities

• Drive regulatory excellence by ensuring compliance with global standards throughout the product lifecycle (R&D to post-market).
• Advise product development teams on regulatory strategy, influencing design, risk management, and labeling decisions.
• Develop and maintain critical regulatory documentation, including DHF, Technical Documentation, DMR, and DHR.
• Prepare, review, and submit documentation for major regulatory bodies, including EU MDR and FDA submissions.
• Participate actively in post-market surveillance, CAPA, and complaint management activities.
• Coordinate communications with regulatory bodies, driving certification projects and vigilance reporting.
• Guide internal teams on integrating regulatory requirements into the Quality Management System and deliver compliance training.

Requirements

• BSc or MSc in law, medicine, pharmacy, engineering, or a related field.
• 4–5+ years of experience in regulatory affairs or quality management specifically for active medical devices and SaMD.
• Deep expertise in EU MDR, FDA CFR (Title 21 Subchapter H), UK MDR, ISO 13485, IEC 60601-1, IEC 62304, and ISO 14971.
• Proven analytical skills with the ability to interpret complex regulations and provide risk-based recommendations.
• Excellent written and verbal communication skills, capable of engaging internal teams and external stakeholders.
• Must be fluent in English.

Nice-to-Haves

• Proficiency in Swedish is a plus.
• Experience working in a highly collaborative and distributed team setting.