Dräger

Team Leader Regulatory Affairs

Dräger

full-time

Posted on:

Location Type: Office

Location: Lübeck • Germany

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Job Level

Senior

About the role

  • Developing global approval strategies for medical devices in the areas of anesthesia, intensive care and warming therapy equipment
  • Leading a Regulatory Affairs team of 13
  • A combination of leadership, advisory work and hands-on implementation (approx. 50%)
  • Objective: accelerate market access and ensure compliance, as well as maintain existing approvals
  • Responsibility for parts of global approval and re-registration strategies
  • Managing implementation through to final documentation (excluding the US market)
  • Technical and disciplinary leadership of the Regulatory Affairs team (13 employees)
  • Actively supporting regulatory interactions (national and international)

Requirements

  • University degree in a technical or scientific discipline, or equivalent
  • Many years of professional experience and ideally initial leadership experience in an internationally oriented Regulatory Affairs function
  • Solid, up-to-date knowledge of international approval requirements, product liability and relevant medical device standards/regulations (e.g. ISO 13485, ISO 14971, 21 CFR Part 820, MDR)
  • Very good knowledge of regulatory software and databases
  • Business-fluent English skills
Benefits
  • No specific benefits mentioned
Applicant Tracking System Keywords

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

Hard Skills & Tools
regulatory affairsglobal approval strategiesmedical device standardsproduct liabilityISO 13485ISO 1497121 CFR Part 820MDRdocumentation managementmarket access
Soft Skills
leadershipadvisory skillsteam managementcommunicationinterpersonal skillsimplementation skillsorganizational skillsproblem-solvingcollaborationstrategic thinking