Head of Regulatory Affairs

About the role

Datwyler is seeking a Head of Regulatory Affairs to build and lead a strategic regulatory capability, initially focused on the Healthcare injectable primary packaging business and later expanding to Medical Device, Food & Beverage and selected industrial markets.

Key responsibilities

• Define and execute a global Regulatory Affairs strategy aligned with business priorities.
• Monitor, interpret and translate evolving regulatory requirements and industry trends across worldwide markets.
• Provide strategic regulatory guidance for new products, materials, technologies and growth initiatives.
• Develop regulatory roadmaps that support product development, manufacturing and commercial launch.
• Ensure regulatory compliance throughout the product lifecycle, including documentation, submissions and change management.
• Collaborate with R&D, Product Management, Quality, Manufacturing, Operations, Commercial, Legal, customers, regulatory bodies and Notified Bodies.
• Lead regulatory intelligence activities and communicate regulatory considerations to internal and external stakeholders.

Required profile

• Proven experience leading regulatory affairs at a global or multi‑regional level.
• Deep knowledge of healthcare regulatory frameworks and familiarity with medical device, food & beverage regulations.
• Strong ability to work cross‑functionally with R&D, quality, manufacturing and commercial teams.
• Strategic mindset with the capacity to translate regulatory developments into business insights.

Required skills