Sartorius Stedim Biotech GmbH
Regulatory Affairs Professional Medical Devices(m/w/x)
Full-timeWith HomeofficeExperienced
Göttingen
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SASartorius Stedim Biotech GmbH
Quality and Regulatory Compliance Auditor(m/w/x)
Göttingen
Full-timeWith Home OfficeExperienced
Nejo AI Summary
Managing quality audit programs and regulatory affairs for a global life science company. Supervisory experience in regulated environments and medical device ISO certifications required. 35-hour work week, 30 vacation days.
Requirements
- Master's degree in scientific discipline or comparable
- Supervisory experience in regulated environment
- Medical device and ISO certification qualifications
- Effective collaboration in cross-functional teams
- Experience with notified bodies and auditing
- Qualification as medical device manufacturing auditor
- Knowledge in regulations and authority interfacing
- Expertise in major regulatory submissions
- Strong interpersonal and personnel dealing skills
- Advanced organizational and prioritization skills
- Business fluent German and English skills
- Willingness to travel approximately 20%
Tasks
- Manage the business unit quality audit program
- Provide specialist input for regulatory affairs processes
- File applications and manage interactions with authorities
- Write and review governing quality system procedures
- Support continuous process improvement efforts
- Maintain risk assessments for compliance-related elements
- Monitor staff training records and personnel files
- Track deviations and master schedules
- Review protocols and reports for internal and external projects
- Coordinate responses to observations and incidents
- Update databases to ensure accuracy and compliance
- Prepare and edit documentation for regulatory submissions
- Develop operating guidelines and shared work practices
- Create optimal strategies for assigned projects
- Implement regulatory strategies for upcoming regulations
- Offer guidance to multidisciplinary teams on compliance
- Train and mentor team members and consultants
Work Experience
- approx. 1 - 4 years
Education
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- ISO related certifications
Benefits
More Vacation Days
- Vacation bonus
- 30 vacation days
Bonuses & Incentives
- Holiday bonus
Retirement Plans
- Pension benefits
Mentorship & Coaching
- Mentoring
- Talent Talks
- Coaching for managers
- Buddy program
- Coaching communities
Career Advancement
- Leadership programs
- Business women network
Learning & Development
- Internal seminar offerings
- Welcome Workshops
Flexible Working
- Remote options
- Flextime
- Flexible work schedules
Workation & Sabbatical
- Sabbaticals
Modern Office
- Open office spaces
- Terraces
Free or Subsidized Food
- Company restaurant
- Vegetarian and vegan options
- Bistro with ice cream
Healthcare & Fitness
- Fitness studio
Childcare
- Daycare center
Other Benefits
- Comprehensive onboarding
- Virtual onboarding platform
Informal Culture
- Mutual support and teamspirit
- International collaboration
Startup Environment
- Agile working communities
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
Quality and Regulatory Compliance Auditor(m/w/x)
Göttingen
Full-timeWith Home OfficeExperienced
Nejo AI Summary
Managing quality audit programs and regulatory affairs for a global life science company. Supervisory experience in regulated environments and medical device ISO certifications required. 35-hour work week, 30 vacation days.
Requirements
- Master's degree in scientific discipline or comparable
- Supervisory experience in regulated environment
- Medical device and ISO certification qualifications
- Effective collaboration in cross-functional teams
- Experience with notified bodies and auditing
- Qualification as medical device manufacturing auditor
- Knowledge in regulations and authority interfacing
- Expertise in major regulatory submissions
- Strong interpersonal and personnel dealing skills
- Advanced organizational and prioritization skills
- Business fluent German and English skills
- Willingness to travel approximately 20%
Tasks
- Manage the business unit quality audit program
- Provide specialist input for regulatory affairs processes
- File applications and manage interactions with authorities
- Write and review governing quality system procedures
- Support continuous process improvement efforts
- Maintain risk assessments for compliance-related elements
- Monitor staff training records and personnel files
- Track deviations and master schedules
- Review protocols and reports for internal and external projects
- Coordinate responses to observations and incidents
- Update databases to ensure accuracy and compliance
- Prepare and edit documentation for regulatory submissions
- Develop operating guidelines and shared work practices
- Create optimal strategies for assigned projects
- Implement regulatory strategies for upcoming regulations
- Offer guidance to multidisciplinary teams on compliance
- Train and mentor team members and consultants
Work Experience
- approx. 1 - 4 years
Education
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- ISO related certifications
Benefits
More Vacation Days
- Vacation bonus
- 30 vacation days
Bonuses & Incentives
- Holiday bonus
Retirement Plans
- Pension benefits
Mentorship & Coaching
- Mentoring
- Talent Talks
- Coaching for managers
- Buddy program
- Coaching communities
Career Advancement
- Leadership programs
- Business women network
Learning & Development
- Internal seminar offerings
- Welcome Workshops
Flexible Working
- Remote options
- Flextime
- Flexible work schedules
Workation & Sabbatical
- Sabbaticals
Modern Office
- Open office spaces
- Terraces
Free or Subsidized Food
- Company restaurant
- Vegetarian and vegan options
- Bistro with ice cream
Healthcare & Fitness
- Fitness studio
Childcare
- Daycare center
Other Benefits
- Comprehensive onboarding
- Virtual onboarding platform
Informal Culture
- Mutual support and teamspirit
- International collaboration
Startup Environment
- Agile working communities
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
Pharmaceuticals
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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