Associate Director, Regulatory Affairs - Digital Health, Device & Combination Products (all gender)

Merck (Schweiz) AG seeks an Associate Director for Regulatory Affairs to lead global strategy for digital health, device, and combination products in Eysins, CH.

This position serves as the primary Device Regulatory Lead within a cross-functional team, operating with significant autonomy. The incumbent is responsible for driving the global regulatory strategy for drug-device combination products from early development through approval and lifecycle management, while influencing both internal decisions and external regulatory outcomes.

Responsibilities

• Prepare and submit scientifically robust, compliant, and timely dossiers to health authorities across the globe.
• Establish and maintain trusted partnerships with regulatory agencies worldwide.
• Convert complex regulatory mandates into clear, actionable strategic plans.
• Serve as a key spokesperson during engagements with regulatory bodies.
• Foster a culture of regulatory excellence and risk-based decision-making within the R&D organization.

Requirements

• Possess a minimum MSc degree in life sciences or a related field.
• Demonstrate at least ten years of experience in regulatory affairs.
• Show proven, recent expertise in submissions for drug-device combination products and/or medical devices in the US, EU, and international markets.
• Exhibit strong capability in developing global regulatory strategies and assembling submission dossiers.
• Maintain a solid understanding of the regulatory frameworks for drug-device combinations and medical devices in the EU, US, and other international regions.
• Be fluent in English.

Nice to have

• A PhD in a scientific discipline is preferred.
• International work experience is highly valued.
• Prior background in regulatory CMC and connected drug-device combination products for medicinal products is advantageous.
• Proficiency in languages other than English is an asset.

What the company offers

• Access to global opportunities for personal development and career advancement.
• A working environment that is diverse, inclusive, and flexible.
• A commitment to creating equal access and opportunities for all employees to grow at their own pace.

About the company

Merck (Schweiz) AG leverages science and technology to enrich lives through solutions in Healthcare, Life Science, and Electronics. The organization is dedicated to sparking discovery and elevating humanity, with a specific purpose in Healthcare to help create, improve, and prolong lives. It values a rich mix of people, customers, patients, and the planet, believing that variety in backgrounds and perspectives drives innovation and excellence.

• Innovation driven by science and technology to improve human well-being.
• Passion for caring for people, customers, patients, and the planet.
• Purpose focused on creating, improving, and prolonging lives in Healthcare.
• Belief that diverse backgrounds and perspectives foster excellence.
• Commitment to sparking discovery and elevating humanity.