W.O.M. World of Medicine GmbH
Senior Regulatory Affairs Specialist Medical Devices(m/w/x)
Full-timeOn-siteSenior
Berlin
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Ensuring product compliance with global regulations for mission-critical healthcare and manufacturing components. 1-2 years of relevant experience and strong problem-solving skills required. Focus on registration-document compilation for third countries.
Requirements
- 1-2 years relevant professional experience
- Extensive research ability, in-depth knowledge, creativity
- Complex problem anticipation, identification, definition, and solving
- General manufacturing process knowledge
- Quality-consciousness, trustworthiness, reliability
- Team player skills
- Communicative skills
- Structured and systematic working method
- Independent English use (CEFR-B2)
Tasks
- Ensure product compliance with regulations and guidelines
- Evaluate regulations and guidelines
- Liaise with regulatory authorities
- Guide internal teams on regulatory matters
- Compile registration-relevant documents for third countries
- Prepare free sales certificates, legalizations, and other declarations
- Compile documents for Notified Body documentation tests
- Support control and acceptance of technical documentation
- Assess compliance with Essential Requirements
- Prepare and release declarations of conformity
- Participate in risk management process implementation
- Conduct clinical evaluations and usability file reviews
- Elaborate and update design guidance procedures
- Review and approve regulatory documents
- Review Risk Analysis and Risk Management documents
- Evaluate Clinical Evaluation, Design Validation, and Design Verification Plans
- Review Software Documentation, Instructions for Use, and Product Labels
- Process change requests and check approval relevance
- Assist with general regulatory inquiries
- Serve as interface to customer RA departments
- Coordinate and cooperate with Notified Body and authorities
- Accompany audits from customers, authorities, and suppliers
- Participate in QMS maintenance measures
- Adapt processes to maintain QMS
- Participate in the innovation process
- Comply with quality, occupational safety, and environmental regulations
- Implement instructions from quality and environmental management
- Make decisions and provide solutions to complex problems
- Act as a consultant to less experienced personnel
- Train less experienced personnel
Work Experience
- 1 - 2 years
Education
- High school diploma
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novanta 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.O.M. World of Medicine GmbH
Lead Regulatory Affairs Specialist Medical Devices(m/w/x)
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Full-time/Part-timeOn-siteExperiencedBerlin - Hach
Product Compliance Expert(m/w/x)
Full-timeOn-siteExperiencedBerlin
Ensuring product compliance with global regulations for mission-critical healthcare and manufacturing components. 1-2 years of relevant experience and strong problem-solving skills required. Focus on registration-document compilation for third countries.
Requirements
- 1-2 years relevant professional experience
- Extensive research ability, in-depth knowledge, creativity
- Complex problem anticipation, identification, definition, and solving
- General manufacturing process knowledge
- Quality-consciousness, trustworthiness, reliability
- Team player skills
- Communicative skills
- Structured and systematic working method
- Independent English use (CEFR-B2)
Tasks
- Ensure product compliance with regulations and guidelines
- Evaluate regulations and guidelines
- Liaise with regulatory authorities
- Guide internal teams on regulatory matters
- Compile registration-relevant documents for third countries
- Prepare free sales certificates, legalizations, and other declarations
- Compile documents for Notified Body documentation tests
- Support control and acceptance of technical documentation
- Assess compliance with Essential Requirements
- Prepare and release declarations of conformity
- Participate in risk management process implementation
- Conduct clinical evaluations and usability file reviews
- Elaborate and update design guidance procedures
- Review and approve regulatory documents
- Review Risk Analysis and Risk Management documents
- Evaluate Clinical Evaluation, Design Validation, and Design Verification Plans
- Review Software Documentation, Instructions for Use, and Product Labels
- Process change requests and check approval relevance
- Assist with general regulatory inquiries
- Serve as interface to customer RA departments
- Coordinate and cooperate with Notified Body and authorities
- Accompany audits from customers, authorities, and suppliers
- Participate in QMS maintenance measures
- Adapt processes to maintain QMS
- Participate in the innovation process
- Comply with quality, occupational safety, and environmental regulations
- Implement instructions from quality and environmental management
- Make decisions and provide solutions to complex problems
- Act as a consultant to less experienced personnel
- Train less experienced personnel
Work Experience
- 1 - 2 years
Education
- High school diploma
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novanta 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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Novanta
Industry
Healthcare
Description
The company powers technology products that transform healthcare and advanced manufacturing, enhancing productivity and lives.
Not a perfect match?
- 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 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 - 6280 TIB Molbiol Syntheselabor GmbH
Regulatory Affairs Manager(m/w/x)
Full-time/Part-timeOn-siteExperiencedBerlin - Hach
Product Compliance Expert(m/w/x)
Full-timeOn-siteExperiencedBerlin