W.O.M. World of Medicine GmbH
Medical Affairs Manager(m/w/x)
Full-timeOn-siteExperienced
Berlin
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W.W.O.M. World of Medicine GmbH
Medical Affairs Manager Medical Devices(m/w/x)
Berlin
Full-timeOn-siteExperienced
AI/ML
Nejo AI Summary
Clinical evaluation and safety reporting for minimally invasive surgery and robotics components at medical technology manufacturer. Expert medical writing and database management for MDR-compliant documentation required. Post-market surveillance focus, 30 days vacation.
Requirements
- University degree in life/natural science or equivalent
- Medical device industry professional experience
- Basic understanding of Medical Affairs processes
- Expert medical writing and database management
- Creation of Clinical Evaluation Plans and Reports
- Strong attention to detail and documentation
- Knowledge of regulatory requirements (MDR, ISO)
- Knowledge of Minimally Invasive Surgery application
- Expertise in Medical Device clinical investigation
- Fluent English and German language skills
- Open and competent stakeholder management attitude
- IT affinity and MS Office proficiency
- Familiarity with AI tools
- Willingness to travel by public transportation
- Valid passport for international travel
Tasks
- Ensure product compliance with regulations and guidelines
- Implement procedures demonstrating clinical performance and safety
- Maintain audit-ready documentation required by MDR and MEDDEV
- Update Post Market Surveillance plans and reports
- Manage Periodic Safety Update Reports for products
- Develop Post-Market Clinical Follow-up plans and reports
- Create Clinical Evaluation plans and reports
- Manage documentation for new and legacy products
- Oversee Medical Affairs processes including Risk and Change Management
- Manage Nonconformance and Corrective and Preventive Actions
- Conduct scientific literature and vigilance searches
- Evaluate searches according to MDR and MEDDEV standards
- Plan studies for CE-registrations and PMCF
- Coordinate with Regulatory Affairs and Product Management
- Collaborate with R&D and external service providers
- Conduct annual PMCF surveys in hospital environments
- Participate in professional conferences to gain clinical insights
- Comply with quality and occupational safety regulations
- Follow environmental management and safety specialist instructions
Work Experience
- approx. 1 - 4 years
Education
- Vocational certification
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- MS Office
- AI tools
- PRISMA
- PICO
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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W.W.O.M. World of Medicine GmbH
Medical Affairs Manager Medical Devices(m/w/x)
Berlin
Full-timeOn-siteExperienced
AI/ML
Nejo AI Summary
Clinical evaluation and safety reporting for minimally invasive surgery and robotics components at medical technology manufacturer. Expert medical writing and database management for MDR-compliant documentation required. Post-market surveillance focus, 30 days vacation.
Requirements
- University degree in life/natural science or equivalent
- Medical device industry professional experience
- Basic understanding of Medical Affairs processes
- Expert medical writing and database management
- Creation of Clinical Evaluation Plans and Reports
- Strong attention to detail and documentation
- Knowledge of regulatory requirements (MDR, ISO)
- Knowledge of Minimally Invasive Surgery application
- Expertise in Medical Device clinical investigation
- Fluent English and German language skills
- Open and competent stakeholder management attitude
- IT affinity and MS Office proficiency
- Familiarity with AI tools
- Willingness to travel by public transportation
- Valid passport for international travel
Tasks
- Ensure product compliance with regulations and guidelines
- Implement procedures demonstrating clinical performance and safety
- Maintain audit-ready documentation required by MDR and MEDDEV
- Update Post Market Surveillance plans and reports
- Manage Periodic Safety Update Reports for products
- Develop Post-Market Clinical Follow-up plans and reports
- Create Clinical Evaluation plans and reports
- Manage documentation for new and legacy products
- Oversee Medical Affairs processes including Risk and Change Management
- Manage Nonconformance and Corrective and Preventive Actions
- Conduct scientific literature and vigilance searches
- Evaluate searches according to MDR and MEDDEV standards
- Plan studies for CE-registrations and PMCF
- Coordinate with Regulatory Affairs and Product Management
- Collaborate with R&D and external service providers
- Conduct annual PMCF surveys in hospital environments
- Participate in professional conferences to gain clinical insights
- Comply with quality and occupational safety regulations
- Follow environmental management and safety specialist instructions
Work Experience
- approx. 1 - 4 years
Education
- Vocational certification
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- MS Office
- AI tools
- PRISMA
- PICO
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(m/w/x)
Full-timeOn-siteExperiencedBerlin - W.O.M. World of Medicine GmbH
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Product Manager Medical Devices(m/w/x)
Full-timeOn-siteExperiencedBerlin - W.O.M. World of Medicine GmbH
Senior Regulatory Affairs Specialist Medical Devices(m/w/x)
Full-timeOn-siteSeniorBerlin - W.O.M. World of Medicine GmbH
Lead Regulatory Affairs Specialist(m/w/x)
Full-timeOn-siteSeniorBerlin