Head of Quality and Regulatory Affairs (m/w/d)

In this leadership role, you own and steer the Quality & Regulatory Affairs function within a fast-growing MedTech company. You will define regulatory strategies across the product lifecycle and ensure compliance with MDR and ISO 13485, while driving QMS improvements. You’ll partner with R&D, Medical, and Commercial teams in an international matrix to enable safe, compliant products. This position offers high visibility, strategic impact, and the chance to shape regulatory and quality directions in a cutting‑edge technology setting with meaningful patient impact.

• competitive compensation package
• long-term career development opportunities
• international, innovative environment
• high-visibility leadership role
• opportunity to shape regulatory and quality strategy

• Lead the Q&R function and team development
• Define and execute regulatory strategies across the product lifecycle
• Ensure compliance with MDR, ISO 13485 and relevant standards
• Oversee QMS management and continuous improvement
• Manage regulatory submissions, approvals, and interactions with authorities and notified bodies
• Act as strategic partner to R&D, Medical, and Commercial functions

• Proven leadership in Quality and/or Regulatory Affairs in a highly regulated industry (ideally MedTech)
• Deep expertise in EU MDR and ISO 13485
• Track record of building and developing high-performing teams
• Strategic mindset with hands-on execution capability
• Excellent stakeholder management in international matrix environments
• Degree in Life Sciences, Engineering, or related field

• stakeholder management
• leadership
• strategic thinking
• EU MDR
• ISO 13485
• QMS management