Boehringer Ingelheim
Regulatory Affairs Manager(m/w/x)
Full-timeWith HomeofficeExperienced
Basel
New Job?Nejo!
Your personal AI career agent
GEGetinge Schweiz AG
QRC Manager(m/w/x)
Rheinfelden
Full-timeWith Home OfficeSenior
Nejo AI Summary
Ensuring Swiss medical device regulatory compliance and managing CH-REP/Importer documentation for a life science solutions provider. Approximately 5 years of medical device QM experience required. Hybrid work, 30 vacation days, and modern equipment.
Requirements
- Bachelor’s or Master’s degree in Engineering, Life Sciences, Quality Management, Regulatory Affairs, or related technical/scientific field
- Approximately 5 years of experience in Quality Management within the medical device industry
- Hands-on experience with ISO 13485 and ISO 9001
- Experience in Sales & Service, distribution, or importer environments preferred
- Knowledge of Swiss medical device regulations and CH-REP / Importer roles is a strong advantage
- Solid understanding of regulatory and quality requirements for medical devices
- Structured, detail-oriented, and solution-driven working style
- Ability to work independently and take ownership of quality topics
- Strong communication and stakeholder management skills
- Fluent in English; German is an advantage
Tasks
- Ensure compliance with Swiss medical device regulations
- Maintain CH-REP and Importer documentation
- Control CH-REP and Importer registers
- Act as primary contact for Swiss authorities
- Support vigilance activities and post-market surveillance
- Manage field safety corrective actions
- Ensure regulatory alignment for Swiss market products
- Maintain and improve QMS according to ISO 13485 and ISO 9001
- Ensure effective document and record control
- Support management reviews and KPI tracking
- Ensure local process compliance with QMS
- Prepare and support internal and external audits
- Act as local Quality representative during audits
- Manage CAPAs and non-conformities
- Implement risk-based improvement measures
- Follow up on audit findings
- Coordinate quality and regulatory training
- Ensure employee competence and awareness
- Promote quality and compliance culture
- Collaborate with Global Quality and Regulatory Affairs
- Support quality-related topics with distributors
- Provide quality input for business decisions
Work Experience
- 5 years
Education
- Master's degree
Languages
- English – Fluent
Tools & Technologies
- ISO 13485
- ISO 9001
Benefits
Flexible Working
- Hybrid work (3-4 days at home)
- Trusted working hours
- Mobile working
More Vacation Days
- 30 vacation days
Modern Equipment
- Modern workplace equipment
Other Benefits
- JobRad
Corporate Discounts
- Corporate benefits
- Employee discounts
Career Advancement
- Career opportunities
Learning & Development
- Individual training
- Further education opportunities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Getinge Schweiz AG 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.
Not a perfect match?
- Novartis
Site Quality Head(m/w/x)
Full-timeWith HomeofficeSeniorBasel - Novartis Pharma Stein AG
Postgraduate QC Mikrobiologie(m/w/x)
Full-timeInternshipWith HomeofficeStein - IQVIA
Clinical Research Associate or SrCRA(m/w/x)
Full-timeWith HomeofficeExperiencedBasel - Novartis Pharma Stein AG
Postgraduate QC Mikrobiologie(m/w/x)
Full-timeInternshipWith HomeofficeStein
GEGetinge Schweiz AG
QRC Manager(m/w/x)
Rheinfelden
Full-timeWith Home OfficeSenior
Nejo AI Summary
Ensuring Swiss medical device regulatory compliance and managing CH-REP/Importer documentation for a life science solutions provider. Approximately 5 years of medical device QM experience required. Hybrid work, 30 vacation days, and modern equipment.
Requirements
- Bachelor’s or Master’s degree in Engineering, Life Sciences, Quality Management, Regulatory Affairs, or related technical/scientific field
- Approximately 5 years of experience in Quality Management within the medical device industry
- Hands-on experience with ISO 13485 and ISO 9001
- Experience in Sales & Service, distribution, or importer environments preferred
- Knowledge of Swiss medical device regulations and CH-REP / Importer roles is a strong advantage
- Solid understanding of regulatory and quality requirements for medical devices
- Structured, detail-oriented, and solution-driven working style
- Ability to work independently and take ownership of quality topics
- Strong communication and stakeholder management skills
- Fluent in English; German is an advantage
Tasks
- Ensure compliance with Swiss medical device regulations
- Maintain CH-REP and Importer documentation
- Control CH-REP and Importer registers
- Act as primary contact for Swiss authorities
- Support vigilance activities and post-market surveillance
- Manage field safety corrective actions
- Ensure regulatory alignment for Swiss market products
- Maintain and improve QMS according to ISO 13485 and ISO 9001
- Ensure effective document and record control
- Support management reviews and KPI tracking
- Ensure local process compliance with QMS
- Prepare and support internal and external audits
- Act as local Quality representative during audits
- Manage CAPAs and non-conformities
- Implement risk-based improvement measures
- Follow up on audit findings
- Coordinate quality and regulatory training
- Ensure employee competence and awareness
- Promote quality and compliance culture
- Collaborate with Global Quality and Regulatory Affairs
- Support quality-related topics with distributors
- Provide quality input for business decisions
Work Experience
- 5 years
Education
- Master's degree
Languages
- English – Fluent
Tools & Technologies
- ISO 13485
- ISO 9001
Benefits
Flexible Working
- Hybrid work (3-4 days at home)
- Trusted working hours
- Mobile working
More Vacation Days
- 30 vacation days
Modern Equipment
- Modern workplace equipment
Other Benefits
- JobRad
Corporate Discounts
- Corporate benefits
- Employee discounts
Career Advancement
- Career opportunities
Learning & Development
- Individual training
- Further education opportunities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Getinge Schweiz AG 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
Getinge Schweiz AG
Industry
Healthcare
Description
Getinge bietet Krankenhäusern und Life-Science-Einrichtungen Produkte und Lösungen zur Verbesserung klinischer Ergebnisse und Arbeitsabläufe. Das Angebot umfasst Produkte für Intensivmedizin, kardiovaskuläre Eingriffe, Operationssäle, Sterilgutaufbereitung und Life Science.
Not a perfect match?
- Boehringer Ingelheim
Regulatory Affairs Manager(m/w/x)
Full-timeWith HomeofficeExperiencedBasel - Novartis
Site Quality Head(m/w/x)
Full-timeWith HomeofficeSeniorBasel - Novartis Pharma Stein AG
Postgraduate QC Mikrobiologie(m/w/x)
Full-timeInternshipWith HomeofficeStein - IQVIA
Clinical Research Associate or SrCRA(m/w/x)
Full-timeWith HomeofficeExperiencedBasel - Novartis Pharma Stein AG
Postgraduate QC Mikrobiologie(m/w/x)
Full-timeInternshipWith HomeofficeStein