Sartorius Stedim Biotech GmbH
Quality and Regulatory Compliance Auditor(m/w/x)
Full-timeWith HomeofficeExperienced
Göttingen
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SASartorius Stedim Biotech GmbH
Regulatory Affairs Professional Medical Devices(m/w/x)
Göttingen
Full-timeWith Home OfficeExperienced
Nejo AI Summary
Preparing clinical and post-market surveillance documents for IVDs and related technical documentation in the EU at a global life science company translating scientific discoveries. Master's degree in natural sciences or related field, with first Regulatory Affairs experience for IVDs essential. 30 vacation days, remote options.
Requirements
- Master’s degree in natural sciences, medical technology, biotechnology, or comparable field
- First experience in Regulatory Affairs for Medical Devices and/or In Vitro Diagnostics
- Experience in scientific writing, especially Post-Market Surveillance and clinical documents
- Knowledge in interpretation of regulations and cooperation with regulatory authorities
- Excellent organizational skills and ability to set priorities
- Excellent analytical skills and knowledge of scientific principles
- Assertiveness, resilience, good sense for counterpart, clear communication, and people management skills
- Fluent German and English skills, both spoken and written
Tasks
- Prepare clinical and performance data documents
- Create post-market surveillance documents for medical devices and IVDs
- Support the Regulatory Affairs Specialist with technical documentation in the EU
- Develop schedules and ensure compliance
- Monitor market developments and conduct research
- Evaluate research findings
- Perform risk assessments and initiate corrective actions for incidents
- Analyze new regulatory requirements and implement necessary activities
- Advise internal stakeholders on regulatory changes and standards
- Communicate with authorities and submit regulatory documents
- Assess the regulatory impact of product changes
- Develop and implement new processes to meet regulatory requirements
- Write procedures and work instructions
- Monitor compliance with regulatory procedures and workflows
Work Experience
- approx. 1 - 4 years
Education
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Benefits
Competitive Pay
- Attractive compensation
Bonuses & Incentives
- Vacation and holiday bonuses
Retirement Plans
- Pension benefits
More Vacation Days
- 30 vacation days
Flexible Working
- Remote options
- Flextime
- Flexible work schedules
Workation & Sabbatical
- Sabbaticals
Modern Office
- Open office spaces
Free or Subsidized Food
- Company restaurant with vegetarian and vegan options
Healthcare & Fitness
- Fitness studio
Childcare
- Daycare center
Other Benefits
- Comprehensive onboarding
- Mutual support
Informal Culture
- Team spirit
- International collaboration
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Sartorius Stedim Biotech 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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SASartorius Stedim Biotech GmbH
Regulatory Affairs Professional Medical Devices(m/w/x)
Göttingen
Full-timeWith Home OfficeExperienced
Nejo AI Summary
Preparing clinical and post-market surveillance documents for IVDs and related technical documentation in the EU at a global life science company translating scientific discoveries. Master's degree in natural sciences or related field, with first Regulatory Affairs experience for IVDs essential. 30 vacation days, remote options.
Requirements
- Master’s degree in natural sciences, medical technology, biotechnology, or comparable field
- First experience in Regulatory Affairs for Medical Devices and/or In Vitro Diagnostics
- Experience in scientific writing, especially Post-Market Surveillance and clinical documents
- Knowledge in interpretation of regulations and cooperation with regulatory authorities
- Excellent organizational skills and ability to set priorities
- Excellent analytical skills and knowledge of scientific principles
- Assertiveness, resilience, good sense for counterpart, clear communication, and people management skills
- Fluent German and English skills, both spoken and written
Tasks
- Prepare clinical and performance data documents
- Create post-market surveillance documents for medical devices and IVDs
- Support the Regulatory Affairs Specialist with technical documentation in the EU
- Develop schedules and ensure compliance
- Monitor market developments and conduct research
- Evaluate research findings
- Perform risk assessments and initiate corrective actions for incidents
- Analyze new regulatory requirements and implement necessary activities
- Advise internal stakeholders on regulatory changes and standards
- Communicate with authorities and submit regulatory documents
- Assess the regulatory impact of product changes
- Develop and implement new processes to meet regulatory requirements
- Write procedures and work instructions
- Monitor compliance with regulatory procedures and workflows
Work Experience
- approx. 1 - 4 years
Education
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Benefits
Competitive Pay
- Attractive compensation
Bonuses & Incentives
- Vacation and holiday bonuses
Retirement Plans
- Pension benefits
More Vacation Days
- 30 vacation days
Flexible Working
- Remote options
- Flextime
- Flexible work schedules
Workation & Sabbatical
- Sabbaticals
Modern Office
- Open office spaces
Free or Subsidized Food
- Company restaurant with vegetarian and vegan options
Healthcare & Fitness
- Fitness studio
Childcare
- Daycare center
Other Benefits
- Comprehensive onboarding
- Mutual support
Informal Culture
- Team spirit
- International collaboration
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Sartorius Stedim Biotech 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
Sartorius Stedim Biotech GmbH
Industry
Healthcare
Description
The company is a growing global life science company that helps translate scientific discoveries into real-world medicine.
Not a perfect match?
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