Head of Regulatory Affairs

pSelect how often (in days) to receive an alert: /ppIn 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. /ppOur 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... /ph3Head of Regulatory Affair s /h3pThe bHead of Regulatory Affairs /bestablishes 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. /ppAs 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. /ppThe role provides strategic leadership across Regulatory Affairs and partners closely with RD, 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. /ph3Your Responsibilities /h3ulliDevelop and execute Datwyler's global Regulatory Affairs strategy /liliMonitor and interpret evolving regulatory requirements and industry trends across global markets /liliProvide strategic regulatory guidance for new products, materials, technologies, and growth initiatives /liliTranslate regulatory developments into business insights and actionable recommendations /liliBuild regulatory roadmaps that support business growth and long-term competitiveness /li /ulh3Lead Regulatory Strategy /h3ulliEnsure regulatory compliance throughout the lifecycle of healthcare products and related product portfolios /liliOversee regulatory documentation and submissions supporting customer and business requirements /liliDrive regulatory assessment processes as part of product lifecycle and change management activities /liliEnsure regulatory considerations are integrated into development, manufacturing, and commercial processes /liliSupport global change notification and customer communication activities /liliEstablish a proactive regulatory intelligence capability covering relevant global regulations, standards, and industry requirements /liliAssess emerging regulatory trends and evaluate potential business impact /liliRepresent Datwyler in industry associations, technical committees, and regulatory forums /liliBuild strong relationships with external stakeholders, including customers and regulatory authorities /li /ulh3Partner with Customers /h3ulliProvide regulatory expertise to customers throughout product development, qualification, and commercialization activities /liliSupport customer submissions with the required scientific and regulatory documentation /liliParticipate in customer audits, technical discussions, and strategic reviews /liliServe as a trusted regulatory advisor in key customer engagements /li /ulh3Build and Lead the Global Function /h3ulliDevelop and lead a high-performing global Regulatory Affairs organization /liliEstablish governance, processes, and best practices that support sustainable growth /liliCollaborate closely with cross-functional teams including RD, Quality, Manufacturing, Operations, Commercial, and Legal /liliPromote a strong regulatory culture across the organization through coaching, training, and knowledge sharing /liliSupport innovation initiatives through early regulatory engagement and strategic guidance /li /ulh3Your Profile /h3ulliMaster's degree or PhD in Pharmacy, Chemistry, Biomedical Engineering, Materials Science, Regulatory Affairs, or a related scientific field /liliMinimum 10 years of Regulatory Affairs experience within the pharmaceutical industry /liliAt least 5 years of leadership experience within a global organization /liliStrong understanding of international regulatory frameworks and healthcare industry requirements /liliExperience interacting with regulatory authorities, customers, industry associations, and external stakeholders /liliProven track record of building regulatory strategies and influencing business decisions /