Head of Regulatory Affairs in Altdorf

Select how often (in days) to receive an alert: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 Affair sThe Head of Regulatory Affairsestablishes 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 ResponsibilitiesDevelop and execute Datwyler's global Regulatory Affairs strategyMonitor and interpret evolving regulatory requirements and industry trends across global marketsProvide strategic regulatory guidance for new products, materials, technologies, and growth initiativesTranslate regulatory developments into business insights and actionable recommendationsBuild regulatory roadmaps that support business growth and long-term competitivenessLead Regulatory StrategyEnsure regulatory compliance throughout the lifecycle of healthcare products and related product portfoliosOversee regulatory documentation and submissions supporting customer and business requirementsDrive regulatory assessment processes as part of product lifecycle and change management activitiesEnsure regulatory considerations are integrated into development, manufacturing, and commercial processesSupport global change notification and customer communication activitiesEstablish a proactive regulatory intelligence capability covering relevant global regulations, standards, and industry requirementsAssess emerging regulatory trends and evaluate potential business impactRepresent Datwyler in industry associations, technical committees, and regulatory forumsBuild strong relationships with external stakeholders, including customers and regulatory authoritiesPartner with CustomersProvide regulatory expertise to customers throughout product development, qualification, and commercialization activitiesSupport customer submissions with the required scientific and regulatory documentationParticipate in customer audits, technical discussions, and strategic reviewsServe as a trusted regulatory advisor in key customer engagementsBuild and Lead the Global FunctionDevelop and lead a high-performing global Regulatory Affairs organizationEstablish governance, processes, and best practices that support sustainable growthCollaborate closely with cross-functional teams including R&D, Quality, Manufacturing, Operations, Commercial, and LegalPromote a strong regulatory culture across the organization through coaching, training, and knowledge sharingSupport innovation initiatives through early regulatory engagement and strategic guidanceYour ProfileMaster's degree or PhD in Pharmacy, Chemistry, Biomedical Engineering, Materials Science, Regulatory Affairs, or a related scientific fieldMinimum 10 years of Regulatory Affairs experience within the pharmaceutical industryAt least 5 years of leadership experience within a global organizationStrong understanding of international regulatory frameworks and healthcare industry requirementsExperience interacting with regulatory authorities, customers, industry associations, and external stakeholdersProven track record of building regulatory strategies and influencing business decisionsStrong leadership, stakeholder management, and communication skillsAbility to operate effectively in a global, matrix organizationStrategic mindset combined with a pragmatic, hands-on approachPassion for continuous improvement, innovation, and customer successWhat We OfferA unique opportunity to build and shape a global Regulatory Affairs functionHigh visibility and influence within a leading international healthcare organizationThe chance to work at the intersection of innovation, quality, and regulatory excellenceAn entrepreneurial environment where you can make a lasting impact on the future of the businessCompetitive compensation and development opportunities within a global companyBe yourself at DatwylerWe are convinced that people make the difference. At Datwyler, you will experience diversity and a wide range of career opportunities that only an international company can provide. Together, we are increasing our agility, accelerating digitalization and fostering sustainability. For motivated and talented employees, we offer interesting development opportunities with training and assignments in a global environment. With us, you can contribute with all of your creativity and all your ideas. #J-18808-Ljbffr