Head of Regulatory Affairs

In billions of syringes and in every second car worldwide, Datwyler components make an important contribution to the safety of patients and drivers. The high-tech company focuses on high-quality, system-critical elastomer components and holds leading positions in attractive global markets such as healthcare, mobility, connectivity, general industry and food & beverage. With over 25 production sites on four continents, sales in more than 100 countries and over 8,000 employees, the company, headquartered in Switzerland, generates annual sales of more than CHF 1,000 million.

Our employees are the heart of Datwyler - we treat each other with respect, trust and appreciation. We have strong roots and values that have been well established in our 100-year corporate history. Become part of our great team as a...

Head of Regulatory Affairs The Head of Regulatory Affairs establishes and leads Regulatory Affairs as a strategic capability for Datwyler, anchored first in Healthcare’s injectable primary packaging business and designed to scale over time across Datwyler’s broader served markets, including Medical Device, Food & Beverage, and selected industrial applications. As the global regulatory leader, the position defines Datwyler’s regulatory affairs strategy across applicable frameworks, regulations, standards, and customer expectations, prioritizing the regulatory complexity and business criticality of Healthcare while progressively extending regulatory discipline to other markets as the function matures. The role provides strategic leadership across Regulatory Affairs and partners closely with R&D, Product Management, Quality, Manufacturing, Operations, Commercial, Legal, external customers, regulatory bodies, and Notified Bodies to position regulatory capability as a source of compliance confidence, customer trust, and enterprise value creation.

Your Responsibilities Lead Regulatory Strategy

Develop and execute Datwyler's global Regulatory Affairs strategy

Monitor and interpret evolving regulatory requirements and industry trends across global markets

Provide strategic regulatory guidance for new products, materials, technologies, and growth initiatives

Translate regulatory developments into business insights and actionable recommendations

Build regulatory roadmaps that support business growth and long-term competitiveness

Ensure Product Regulatory Compliance

Ensure regulatory compliance throughout the lifecycle of healthcare products and related product portfolios

Oversee regulatory documentation and submissions supporting customer and business requirements

Drive regulatory assessment processes as part of product lifecycle and change management activities

Ensure regulatory considerations are integrated into development, manufacturing, and commercial processes

Support global change notification and customer communication activities

Drive Regulatory Intelligence

Establish a proactive regulatory intelligence capability covering relevant global regulations, standards, and industry requirements

Assess emerging regulatory trends and evaluate potential business impact

Represent Datwyler in industry associations, technical committees, and regulatory forums

Build strong relationships with external stakeholders, including customers and regulatory authorities

Partner with Customers

Provide regulatory expertise to customers throughout product development, qualification, and commercialization activities

Support customer submissions with the required scientific and regulatory documentation

Participate in customer audits, technical discussions, and strategic reviews

Serve as a trusted regulatory advisor in key customer engagements

Build and Lead the Global Function

Develop and lead a high-performing global Regulatory Affairs organization

Establish governance, processes, and best practices that support sustainable growth

Collaborate closely with cross-functional teams including R&D, Quality, Manufacturing, Operations, Commercial, and Legal

Promote a strong regulatory culture across the organization through coaching, training, and knowledge sharing

Support innovation initiatives through early regulatory engagement and strategic guidance

Your Profile

Master's degree or PhD in Pharmacy, Chemistry, Biomedical Engineering, Materials Science, Regulatory Affairs, or a related scientific field

Minimum 10 years of Regulatory Affairs experience within the pharmaceutical, medical device, biotechnology, healthcare, or related industries

At least 5 years of leadership experience within a global organization

Strong understanding of international regulatory frameworks and healthcare industry requirements

Experience interac