Dräger

Team Lead, Regulatory Affairs

Dräger

full-time

Posted on:

Location Type: Office

Location: Lübeck • Germany

Visit company website

Explore more

✨ AI Apply
Apply

Job Level

Senior

About the role

  • Develop global regulatory approval strategies for medical devices
  • Provide technical and disciplinary leadership for the Regulatory Affairs team (13 employees)
  • Provide proactive consulting and maintain a clear results focus
  • Actively coordinate exchanges with regulatory authorities
  • Continuously expand knowledge of regulatory requirements and modern methods
  • Hands-on contribution (approx. 50%): take on specific tasks/products to achieve objectives

Requirements

  • Degree in a technical or scientific field or equivalent
  • Many years of professional experience and ideally initial leadership experience in an internationally oriented Regulatory Affairs function
  • Solid, up-to-date expertise in international regulatory requirements, product liability, and relevant medical device standards/regulations (e.g. ISO 13485, ISO 14971, 21 CFR Part 820, MDR)
  • Excellent knowledge of regulatory software and databases and business-fluent (negotiation-level) English
  • Confident communication skills, strong stakeholder management, and clear target/results orientation
Benefits
  • No information on additional benefits
Applicant Tracking System Keywords

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

Hard Skills & Tools
regulatory approval strategiesregulatory requirementsproduct liabilitymedical device standardsISO 13485ISO 1497121 CFR Part 820MDR
Soft Skills
technical leadershipconsultingresults focuscommunication skillsstakeholder managementtarget orientation