Associate Director, Regulatory Affairs – Digital Health & Combination Products

About the role

You will own and drive the global regulatory strategy for drug‑device combination products, guiding them from early development through approval and lifecycle management. As the Device Regulatory Lead, you will work closely with CMC, device engineering and quality teams to ensure compliant, timely submissions worldwide.

Key responsibilities

• Develop and execute global regulatory strategies for combination products across US, EU and other international markets.
• Prepare and submit dossiers such as EU MAA, NBOp, CTA, US IND, NDA, BLA, 510(k) and PMA.
• Lead scientific advice meetings with health authorities and act as the spokesperson for the program.
• Collaborate with cross‑functional teams to align regulatory requirements with product development and quality systems.

Required profile

• Advanced degree in life sciences (MSc minimum; PhD preferred).
• 10+ years of regulatory affairs experience with drug‑device combination products.
• Proven track record of successful submissions and interactions with regulatory agencies.
• Fluent in English; additional languages are a plus.

Required skills

• Expertise in EU MAA, NBOp, CTA, US IND, NDA, BLA, 510(k), PMA submissions.
• Deep knowledge of ICH, EU‑MDR, MDSAP, ISO 13485, cGMP for combination products, QMS, eCTD and MCDG guidelines.
• Experience with regulatory CMC and connected drug‑device combination products.