W.O.M. World of Medicine GmbH
Medical Affairs Manager Medical Devices(m/w/x)
Full-timeOn-siteExperienced
Berlin
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W.W.O.M. World of Medicine GmbH
Medical Affairs Manager(m/w/x)
Berlin
Full-timeOn-siteExperienced
AI/ML
Nejo AI Summary
Managing medical device conformity, PMS/PSUR documentation, and PMCF plans for engineered healthcare components. Medical device industry experience and expert medical writing skills required. Focus on precision engineered components for healthcare and advanced manufacturing.
Requirements
- Degree in life/natural science or equivalent
- Experience in medical device industry
- Understanding of Medical Affairs processes
- Expert knowledge in medical writing
- Creation of Clinical Evaluation Plans
- Strong attention to detail
- Knowledge of regulatory requirements
- Knowledge of Minimally Invasive Surgery
- Knowledge in Clinical investigation
- Fluent English and German skills
- Open and competent stakeholder attitude
- IT affinity and MS Office proficiency
- Familiarity with AI tools
- Willingness to travel on demand
- Valid passport for international travel
- Mobility for standard office work
Tasks
- Maintain product compliance with regulatory guidelines
- Ensure medical device conformity with safety requirements
- Prepare and update PMS and PSUR documentation
- Manage PMCF plans and reports
- Develop clinical evaluation plans and reports
- Maintain audit-ready documentation at all times
- Support risk and change management processes
- Handle nonconformance and corrective actions
- Conduct scientific literature and vigilance searches
- Evaluate data according to MDR and MEDDEV standards
- Plan studies for CE-registrations and PMCF
- Collaborate with R&D and product management teams
- Coordinate with external service providers
- Conduct annual PMCF surveys in hospitals
- Attend conferences to track clinical innovations
- Follow quality and occupational safety regulations
- Implement environmental management instructions
Work Experience
- approx. 1 - 4 years
Education
- Vocational certification
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- PRISMA
- PICO
- MDR
- MDCG
- MEDDEV
- ISO 13485
- ISO 14971
- QSR (FDA)
- ISO 14155
- ISO 14115
- MS Office
- AI tools
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of W.O.M. World of Medicine 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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Senior Regulatory Affairs Specialist Medical Devices(m/w/x)
Full-timeOn-siteSeniorBerlin
W.W.O.M. World of Medicine GmbH
Medical Affairs Manager(m/w/x)
Berlin
Full-timeOn-siteExperienced
AI/ML
Nejo AI Summary
Managing medical device conformity, PMS/PSUR documentation, and PMCF plans for engineered healthcare components. Medical device industry experience and expert medical writing skills required. Focus on precision engineered components for healthcare and advanced manufacturing.
Requirements
- Degree in life/natural science or equivalent
- Experience in medical device industry
- Understanding of Medical Affairs processes
- Expert knowledge in medical writing
- Creation of Clinical Evaluation Plans
- Strong attention to detail
- Knowledge of regulatory requirements
- Knowledge of Minimally Invasive Surgery
- Knowledge in Clinical investigation
- Fluent English and German skills
- Open and competent stakeholder attitude
- IT affinity and MS Office proficiency
- Familiarity with AI tools
- Willingness to travel on demand
- Valid passport for international travel
- Mobility for standard office work
Tasks
- Maintain product compliance with regulatory guidelines
- Ensure medical device conformity with safety requirements
- Prepare and update PMS and PSUR documentation
- Manage PMCF plans and reports
- Develop clinical evaluation plans and reports
- Maintain audit-ready documentation at all times
- Support risk and change management processes
- Handle nonconformance and corrective actions
- Conduct scientific literature and vigilance searches
- Evaluate data according to MDR and MEDDEV standards
- Plan studies for CE-registrations and PMCF
- Collaborate with R&D and product management teams
- Coordinate with external service providers
- Conduct annual PMCF surveys in hospitals
- Attend conferences to track clinical innovations
- Follow quality and occupational safety regulations
- Implement environmental management instructions
Work Experience
- approx. 1 - 4 years
Education
- Vocational certification
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- PRISMA
- PICO
- MDR
- MDCG
- MEDDEV
- ISO 13485
- ISO 14971
- QSR (FDA)
- ISO 14155
- ISO 14115
- MS Office
- AI tools
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of W.O.M. World of Medicine 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
W.O.M. World of Medicine GmbH
Industry
Healthcare
Description
The company creates engineered components and sub-systems for healthcare and advanced manufacturing, enhancing productivity and precision.
Not a perfect match?
- W.O.M. World of Medicine GmbH
Medical Affairs Manager Medical Devices(m/w/x)
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Product Manager Medical Devices(m/w/x)
Full-timeOn-siteExperiencedBerlin - W.O.M. World of Medicine GmbH
Lead Regulatory Affairs Specialist(m/w/x)
Full-timeOn-siteSeniorBerlin - W.O.M. World of Medicine GmbH
Senior Regulatory Affairs Specialist Medical Devices(m/w/x)
Full-timeOn-siteSeniorBerlin