Dräger

Head of Regulatory Affairs, Medical Devices

Dräger

full-time

Posted on:

Location Type: Office

Location: Lübeck • 🇩🇪 Germany

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Job Level

Lead

About the role

  • You develop the overall regulatory strategy for international approvals and re-registrations and manage its implementation by your team through to final documentation.
  • As head of the Regulatory Affairs team (7 employees), you shape the strategic direction of the department and continuously develop structures, processes and methods.
  • As the central regulatory contact within the business unit and for our international sites, you provide proactive advice with a clear focus on our growth objectives.
  • You oversee regulatory interactions at national and international levels and take the lead in strategically important or escalated situations.
  • You continuously expand your knowledge of regulatory requirements and modern methods and actively apply it to the work of the business unit.

Requirements

  • Degree in a technical or natural sciences field, or equivalent qualification.
  • Several years of professional experience and, ideally, initial leadership experience in a comparable, internationally oriented position.
  • Solid and up-to-date knowledge of international regulatory approval requirements, product liability issues, and relevant standards and regulations for medical devices, in particular ISO 13485, ISO 14971, 21 CFR Part 820, and the MDR.
  • Excellent experience with regulatory software and databases, and business‑fluent English skills.
  • Confident communication skills when dealing with various stakeholders and a strong results- and goal-oriented mindset.
Benefits
  • 30 days of annual leave plus company-regulated special leave days.
  • Flexible working hours.
  • Remote work options.
  • Contributions to (company) pension schemes.
  • Discounted employee stock.
  • Individualized onboarding and induction.
  • Networking events.
  • Professional development opportunities and coaching.
  • Company sports and preventive health courses.
  • Family support service with a 24/7 emergency hotline.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
regulatory strategy developmentregulatory approvalsre-registrationsknowledge of international regulatory approval requirementsproduct liability issuesISO 13485ISO 1497121 CFR Part 820MDR
Soft skills
leadership experienceproactive adviceconfident communicationresults-oriented mindsetgoal-oriented mindset