Dräger

Head of Regulatory Affairs – Medical Technology

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 oversee 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 function and continuously improve structures, processes and methods.
  • As the central regulatory point of contact within the Business Unit and for our international sites, you provide proactive advice with a clear focus on our growth objectives.
  • You manage regulatory interactions with authorities 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 incorporate it into the Business Unit’s work.

Requirements

  • Degree in engineering, natural sciences or a related field (or equivalent).
  • Several years of professional experience and, ideally, initial leadership experience in a comparable, internationally oriented role.
  • Solid and up-to-date knowledge of international approval requirements, product liability issues and relevant medical device standards and regulations, in particular ISO 13485, ISO 14971, 21 CFR Part 820 and MDR.
  • Excellent knowledge of regulatory software and databases and business-fluent English.
  • Confident communication skills in interactions with various stakeholders and a strong results- and goal-orientation.
Benefits
  • 30 days of annual leave plus company-designated special leave days
  • Flexible working hours
  • Option to work remotely
  • Contributions to (company) pension schemes
  • Discounted employee share purchase plan
  • Individual onboarding and training
  • Networking events
  • Professional development opportunities and coaching
  • Company sports and prevention courses
  • Family support services 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 & Tools
regulatory strategy developmentinternational approvalsre-registrationsregulatory interactions managementknowledge of ISO 13485knowledge of ISO 14971knowledge of 21 CFR Part 820knowledge of MDRproduct liability issuesregulatory software knowledge
Soft Skills
leadership experienceproactive advicecommunication skillsresults orientationgoal orientationstakeholder interactionstrategic direction shapingprocess improvementteam managementknowledge expansion