Dräger

Team Leader Regulatory Affairs, m/f/d

Dräger

full-time

Posted on:

Location Type: Office

Location: Lübeck • Germany

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Job Level

Senior

About the role

  • Develop global regulatory approval strategies for medical devices in the anesthesia, intensive care and warming-therapy product areas
  • Provide technical and disciplinary leadership for a 13-person Regulatory Affairs team
  • Act as proactive regulatory advisor and primary regulatory contact for the Business Unit
  • Actively manage communications with regulatory authorities and assume a leadership role in strategically important situations
  • Contribute operationally and take on specific tasks to achieve objectives and to support and relieve the team

Requirements

  • Completed degree in a technical or natural sciences discipline, or equivalent qualification
  • Several years of professional experience and ideally initial leadership experience in an internationally oriented Regulatory Affairs function
  • Solid, up-to-date knowledge of international regulatory requirements, product liability, and relevant medical device standards/regulations (e.g., ISO 13485, ISO 14971, 21 CFR Part 820, MDR)
  • Strong experience with regulatory software and databases, and business-fluent English
  • Confident communication skills, strong stakeholder management, and a clear goal/results orientation
Benefits
  • Health protection
  • Retirement provision
  • Flexible working hours
  • Occupational pension (company pension scheme)
Applicant Tracking System Keywords

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

Hard Skills & Tools
regulatory approval strategiesregulatory affairsmedical device standardsproduct liabilityISO 13485ISO 1497121 CFR Part 820MDR
Soft Skills
leadershipcommunication skillsstakeholder managementgoal orientationresults orientation