Senior Specialist (m/f/d) Regulatory Affairs

In this role you drive regulatory compliance across product lifecycles at the Wiesbaden Core Diagnostics site. You partner with QA, R&D and Manufacturing to ensure global regulatory alignment and represent regulatory affairs in cross-functional teams. You act as regulatory SME during audits and support site compliance activities. You will coordinate with international counterparts and contribute to global initiatives that strengthen product compliance and business continuity. This is a chance to shape regulatory strategy in a multinational, science‑driven environment that values impact and collaboration.

• Evaluate lifecycle activities (change management, investigations, CAPAs, post-market) for regulatory impact and strategize accordingly
• Partner with Quality, R&D, Manufacturing, Technical Operations, international affiliates and third-party manufacturers to ensure global compliance
• Act as regulatory SME during internal and external audits
• Support site-related compliance activities, including batch verification processes
• Coordinate with international counterparts for legal document procurement
• Lead or contribute to cross-functional initiatives to strengthen product compliance and business continuity

• 4+ years in Medical Device or IVD industry
• Expertise in QA, CAPA/Investigations, Product Development/R&D, Manufacturing/Technical Operations, or Regulatory Affairs
• Ability to assess complex technical issues and make risk-based decisions across functions
• Experience in audits, inspections, design changes, product lifecycle management, or quality system processes
• Strong communication and stakeholder management in a global environment
• Excellent German and English (written and spoken)

• strong communication
• stakeholder management
• cross-functional collaboration
• Quality Assurance
• CAPA and Investigations
• Product Lifecycle Management