Head of Regulatory Affairs

Shape the Future of Regulatory Excellence at Datwyler

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 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
• Ability to operate effectively in a global, matrix organization
• Strategic mindset combined with a pragmatic, hands-on approach
• Passion for continuous improvement, innovation, and customer success

What We Offer

• 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 within a global company

We 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.