Head Of Regulatory Affairs
Pubblicato il 13-09-2026 - Datwyler Group in Bardi
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 Affairs
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.
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
Be yourself at Datwyler
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.
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