Manager, 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. We have strong roots and values that have been well established in our 100-year corporate history. Head of Regulatory Affair s 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. 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 Assess emerging regulatory trends and evaluate potential business impact 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 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 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 interacting with regulatory authorities, customers, industry associations, and external stakeholders Proven track record of building regulatory strategies and influencing business decisions Strong leadership, stakeholder management, and communication skills Passion for continuous improvement, innovation, and customer success A unique opportunity to build and shape a global Regulatory Affairs function High visibility and influence within a leading international healthcare organization The chance to work at the intersection of innovation, quality, and regulatory excellence An entrepreneurial environment where you can make a lasting impact on the future of the business Competitive compensation and development opportunities