Regulatory Affairs Team Leader
Dräger
full-time
Posted on:
Location Type: Office
Location: Lübeck • Germany
Visit company websiteExplore more
Job Level
About the role
- Developing global regulatory approval strategies for medical devices
- Technical and disciplinary leadership of a 13-member Regulatory Affairs team
- Development and responsibility for components of global registration and re-registration strategies
- Managing implementation through to final documentation
- Proactive regulatory advice
- Actively supporting exchanges with regulatory authorities
- Continuously expanding knowledge of regulatory requirements and modern methodologies
- Approximately 50% hands-on/operational contribution
Requirements
- Degree in a technical or natural science discipline or equivalent
- Several years of professional experience and preferably 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 knowledge of regulatory software and databases and business-fluent (negotiation-level) English
- Confident communicator, strong stakeholder management skills, and clear goal/result orientation
Benefits
- High quality of living
- Cultural and recreational amenities
- Excellent transport links to Hamburg and the Baltic Sea
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory approval strategiesglobal registration strategiesdocumentation managementregulatory adviceregulatory requirements knowledgemedical device standardsISO 13485ISO 1497121 CFR Part 820MDR
Soft Skills
technical leadershipcommunicationstakeholder managementgoal orientationresult orientation