Fresenius Kabi (Schweiz) AG
Junior Quality Manager(m/w/x)
Full-timeWith HomeofficeJunior
Kriens
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FRFresenius Medical Care (Schweiz) AG
Cluster Expert Pre and Pos Market Drugs and Supply Chain Quality(m/w/x)
Oberdorf (NW)
Full-timeWith Home OfficeJunior
Nejo AI Summary
Regulatory and quality lead for cluster, managing registrations and serving as primary contact for authorities and stakeholders. Advanced training in Regulatory Affairs and pharmacovigilance required. Hybrid work, career planning opportunities.
Requirements
- Minimum BA university degree in Pharmacy, Pharmaceutical Sciences, Biochemistry, Biology, Bioengineering, Health Sciences, or similar
- Advanced training in Regulatory Affairs of medicinal products
- Advanced training in pharmacovigilance
- At least 2-4 years experience in similar position
- Minimum 2 years experience in regulatory affairs in MedTech/Pharma industry
- Minimum 2 years experience in regulatory submissions, filings, and compliance
- Minimum 2 years experience in MedTech industry
- Extensive experience processing documentation and controls
- 2-3 years professional experience in GDP-related activities
- At least 1 year experience in pharmacovigilance and knowledge of local regulations
- Good knowledge in applicable legal and regulatory laws
- Good knowledge of ISO 9001, ISO 13485, GxP regulations
- Proficiency in Regulatory Software: Familiarity with regulatory management tools, document management systems, and databases
- High proficiency in MS Office applications, SharePoint, MS-Teams, with ability to adapt to new technologies
- High language proficiency in English and native language (written and spoken)
- Other languages are an asset
Tasks
- Act as regulatory and quality lead for the cluster
- Serve as primary contact for regulatory authorities
- Serve as primary contact for internal stakeholders
- Manage regulatory affairs
- Manage registrations
- Manage renewals
- Manage variations
- Manage product information updates
- Oversee local pharmacovigilance activities
- Ensure compliance with global PV requirements
- Ensure GDP compliance throughout supply chain
- Oversee distributors
- Oversee logistics partners
- Monitor regulatory changes
- Provide regulatory intelligence
- Support audits
- Support inspections
- Drive governance
- Drive GxP training
- Drive continuous improvement initiatives
Work Experience
- 1 year
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- English – Native
- native – Native
Tools & Technologies
- Regulatory Software
- MS Office applications
- SharePoint
- MS-Teams
Benefits
Career Advancement
- Career planning opportunities
Learning & Development
- Professional development
Flexible Working
- Hybrid work
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Fresenius Medical Care (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.
Not a perfect match?
- Merck & Co., Inc.
Quality Assurance Specialist(m/w/x)
Full-timeWith HomeofficeExperiencedLuzern - Fresenius Medical Care
MedTech Digital Project Engineer(m/w/x)
Full-timeWith HomeofficeSeniorOberdorf (NW) - Boston Scientific
Field Clinical Specialist - Electrophysiology(m/w/x)
Full-timeWith HomeofficeExperiencedLuzern - Fresenius Medical Care
Data Governance & Delivery Lead(m/w/x)
Full-timeWith HomeofficeSeniorOberdorf (NW)
FRFresenius Medical Care (Schweiz) AG
Cluster Expert Pre and Pos Market Drugs and Supply Chain Quality(m/w/x)
Oberdorf (NW)
Full-timeWith Home OfficeJunior
Nejo AI Summary
Regulatory and quality lead for cluster, managing registrations and serving as primary contact for authorities and stakeholders. Advanced training in Regulatory Affairs and pharmacovigilance required. Hybrid work, career planning opportunities.
Requirements
- Minimum BA university degree in Pharmacy, Pharmaceutical Sciences, Biochemistry, Biology, Bioengineering, Health Sciences, or similar
- Advanced training in Regulatory Affairs of medicinal products
- Advanced training in pharmacovigilance
- At least 2-4 years experience in similar position
- Minimum 2 years experience in regulatory affairs in MedTech/Pharma industry
- Minimum 2 years experience in regulatory submissions, filings, and compliance
- Minimum 2 years experience in MedTech industry
- Extensive experience processing documentation and controls
- 2-3 years professional experience in GDP-related activities
- At least 1 year experience in pharmacovigilance and knowledge of local regulations
- Good knowledge in applicable legal and regulatory laws
- Good knowledge of ISO 9001, ISO 13485, GxP regulations
- Proficiency in Regulatory Software: Familiarity with regulatory management tools, document management systems, and databases
- High proficiency in MS Office applications, SharePoint, MS-Teams, with ability to adapt to new technologies
- High language proficiency in English and native language (written and spoken)
- Other languages are an asset
Tasks
- Act as regulatory and quality lead for the cluster
- Serve as primary contact for regulatory authorities
- Serve as primary contact for internal stakeholders
- Manage regulatory affairs
- Manage registrations
- Manage renewals
- Manage variations
- Manage product information updates
- Oversee local pharmacovigilance activities
- Ensure compliance with global PV requirements
- Ensure GDP compliance throughout supply chain
- Oversee distributors
- Oversee logistics partners
- Monitor regulatory changes
- Provide regulatory intelligence
- Support audits
- Support inspections
- Drive governance
- Drive GxP training
- Drive continuous improvement initiatives
Work Experience
- 1 year
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- English – Native
- native – Native
Tools & Technologies
- Regulatory Software
- MS Office applications
- SharePoint
- MS-Teams
Benefits
Career Advancement
- Career planning opportunities
Learning & Development
- Professional development
Flexible Working
- Hybrid work
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Fresenius Medical Care (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.
About the Company
Fresenius Medical Care (Schweiz) AG
Industry
Healthcare
Description
Das Unternehmen ist der weltweit führende Anbieter von Produkten und Dienstleistungen für Patienten mit chronischem Nierenversagen.
Not a perfect match?
- Fresenius Kabi (Schweiz) AG
Junior Quality Manager(m/w/x)
Full-timeWith HomeofficeJuniorKriens - Merck & Co., Inc.
Quality Assurance Specialist(m/w/x)
Full-timeWith HomeofficeExperiencedLuzern - Fresenius Medical Care
MedTech Digital Project Engineer(m/w/x)
Full-timeWith HomeofficeSeniorOberdorf (NW) - Boston Scientific
Field Clinical Specialist - Electrophysiology(m/w/x)
Full-timeWith HomeofficeExperiencedLuzern - Fresenius Medical Care
Data Governance & Delivery Lead(m/w/x)
Full-timeWith HomeofficeSeniorOberdorf (NW)