medmix
Quality & Regulatory Affairs Lead(m/w/x)
Full-timeWith HomeofficeManagement
Kiel
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STStryker Trauma GmbH
Senior Staff Regulatory Affairs(m/w/x)
Schönkirchen, Kiel
Full-timeWith Home OfficeSenior
Nejo AI Summary
Global regulatory strategy for innovative medical devices, US and EU compliance. 5+ years medical device RA experience required. Mentoring colleagues, cross-functional team support.
Requirements
- Bachelor's degree in life sciences, engineering, or related field
- 5+ years medical device Regulatory Affairs experience
- Strong knowledge of FDA, EU MDR, and global regulations
- Proven experience with Class II/III medical device submissions
- Excellent English communication skills
- Master's degree or Regulatory Affairs Certification (RAC)
- Experience in orthopedics or implantable devices
- German language skills
- Familiarity with Quality Systems and Design Control
Tasks
- Lead global regulatory strategies for innovative medical devices
- Support cross-functional teams
- Mentor colleagues
- Ensure compliance across international markets (US and EU)
- Lead regulatory strategy for new products and changes
- Prepare and manage submissions (FDA, EU MDR, post-market)
- Act as liaison with regulatory authorities and notified bodies
- Review and approve labeling, marketing, and change documentation
- Support audits and inspections with expert regulatory guidance
- Monitor regulatory trends and communicate updates internally
- Mentor junior RA team members
- Support training activities
- Contribute to process improvements
- Contribute to SOP development
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- FDA
- EU MDR
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Stryker Trauma GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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STStryker Trauma GmbH
Senior Staff Regulatory Affairs(m/w/x)
Schönkirchen, Kiel
Full-timeWith Home OfficeSenior
Nejo AI Summary
Global regulatory strategy for innovative medical devices, US and EU compliance. 5+ years medical device RA experience required. Mentoring colleagues, cross-functional team support.
Requirements
- Bachelor's degree in life sciences, engineering, or related field
- 5+ years medical device Regulatory Affairs experience
- Strong knowledge of FDA, EU MDR, and global regulations
- Proven experience with Class II/III medical device submissions
- Excellent English communication skills
- Master's degree or Regulatory Affairs Certification (RAC)
- Experience in orthopedics or implantable devices
- German language skills
- Familiarity with Quality Systems and Design Control
Tasks
- Lead global regulatory strategies for innovative medical devices
- Support cross-functional teams
- Mentor colleagues
- Ensure compliance across international markets (US and EU)
- Lead regulatory strategy for new products and changes
- Prepare and manage submissions (FDA, EU MDR, post-market)
- Act as liaison with regulatory authorities and notified bodies
- Review and approve labeling, marketing, and change documentation
- Support audits and inspections with expert regulatory guidance
- Monitor regulatory trends and communicate updates internally
- Mentor junior RA team members
- Support training activities
- Contribute to process improvements
- Contribute to SOP development
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- FDA
- EU MDR
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Stryker Trauma GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Stryker Trauma GmbH
Industry
Healthcare
Description
Das Unternehmen ist ein international führendes Medizintechnikunternehmen, das sich für die Verbesserung der Gesundheitsversorgung einsetzt.
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