Head of Regulatory Affairs

pIn 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. /p pOur 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... /p h3Head of Regulatory Affairs /h3 pThe 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. /p pAs 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. /p pThe 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. /p h3Your Responsibilities /h3 h3Lead Regulatory Strategy /h3 ul liDevelop and execute Datwyler's global Regulatory Affairs strategy /li liMonitor and interpret evolving regulatory requirements and industry trends across global markets /li liProvide strategic regulatory guidance for new products, materials, technologies, and growth initiatives /li liTranslate regulatory developments into business insights and actionable recommendations /li liBuild regulatory roadmaps that support business growth and long-term competitiveness /li /ul h3Ensure Product Regulatory Compliance /h3 ul liEnsure regulatory compliance throughout the lifecycle of healthcare products and related product portfolios /li liOversee regulatory documentation and submissions supporting customer and business requirements /li liDrive regulatory assessment processes as part of product lifecycle and change management activities /li liEnsure regulatory considerations are integrated into development, manufacturing, and commercial processes /li liSupport global change notification and customer communication activities /li /ul h3Drive Regulatory Intelligence /h3 ul liEstablish a proactive regulatory intelligence capability covering relevant global regulations, standards, and industry requirements /li liAssess emerging regulatory trends and evaluate potential business impact /li liRepresent Datwyler in industry associations, technical committees, and regulatory forums /li liBuild strong relationships with external stakeholders, including customers and regulatory authorities /li /ul h3Partner with Customers /h3 ul liProvide regulatory expertise to customers throughout product development, qualification, and commercialization activities /li liSupport customer submissions with the required scientific and regulatory documentation /li liParticipate in customer audits, technical discussions, and strategic reviews /li liServe as a trusted regulatory advisor in key customer engagements /li /ul h3Build and Lead the Global Function /h3 ul liDevelop and lead a high-performing global Regulatory Affairs organization /li liEstablish governance, processes, and best practices that support sustainable growth /li liCollaborate closely with cross-functional teams including RD, Quality, Manufacturing, Operations, Commercial, and Legal /li liPromote a strong regulatory culture across the organization through coaching, training, and knowledge sharing /li liSupport innovation initiatives through early regulatory engagement and strategic guidance /li /ul h3Your Profile /h3 ul liMaster's degree or PhD in Pharmacy, Chemistry, Biomedical Engineering, Materials Science, Regulatory Affairs, or a related scientific field /li liMinimum 10 years of Regulatory Affairs experience within the pharmaceutical industry /li liAt least 5 years of leadership experience within a global organization /li liStrong understanding of international regulatory frameworks and healthcare industry requirements /li liExperience interacting with regulatory authorities, customers, industry associations, and external stakeholders /li liProven tra