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

Düsseldorf, Nordrhein-Westfalen Permanent View Job Description
This role offers full ownership of Quality & Regulatory Affairs within an innovative, fast-growing MedTech company, combining strategic leadership with operational impact. You will work closely with international stakeholders while shaping regulatory strategy and ensuring compliance across a cutting-edge product portfolio.
  • You will take on a highly visible leadership role with full ownership
  • Join a dynamic, international company at the forefront of MedTech innovation

About Our Client

Our client is an international, innovation-driven MedTech company with a strong growth trajectory in Europe. The organization operates in a highly regulated environment, combining cutting-edge technology with a clear focus on quality, compliance, and patient impact.

Job Description

  • Full ownership and leadership of the Quality & Regulatory Affairs function, including team development and performance
  • Definition and execution of regulatory strategies across the product lifecycle
  • Ensuring compliance with all relevant regulatory requirements and quality standards (e.g., MDR, ISO 13485)
  • Oversight and continuous improvement of the Quality Management System (QMS)
  • Management of regulatory submissions, approvals, and interactions with authorities and notified bodiesActing as a key strategic partner to internal stakeholders across R&D, Medical, and Commercial functions



The Successful Applicant

  • Proven leadership experience in Quality and/or Regulatory Affairs within a highly regulated industry, ideally MedTech
  • Deep expertise in relevant regulations and quality standards (e.g., EU MDR, ISO 13485)
  • Strong track record in building, leading, and developing high-performing teams
  • Strategic mindset combined with hands-on execution capabilities
  • Excellent stakeholder management skills and ability to operate in an international matrix environment
  • Degree in Life Sciences, Engineering, or a related field



What's on Offer

  • A high-impact leadership position with strong visibility and direct influence on business success
  • An international, innovative MedTech environment with significant growth ambitions
  • The opportunity to shape regulatory and quality strategy in a cutting-edge technology setting
  • A competitive compensation package along with long-term career development opportunities



Contact
Deniz Alkan
Quote job ref
JN-062026-7043610

Job summary

Function
Policy, Economics & Regulatory Affairs
Subsector
Policy, Economics & Regulatory Affairs Subsector
Industry
Life Sciences
Location
Düsseldorf
Contract type
Permanent
Consultant name
Deniz Alkan
Job reference
JN-062026-7043610
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