Thermo Fisher Scientific Inc.
Head of Quality Control and Process Care(m/w/x)
Full-timeOn-siteManagement
Freiburg im Breisgau
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STStryker
Senior Clinical Affairs Specialist(m/w/x)
Freiburg im Breisgau
Full-timeOn-siteSenior
Nejo AI Summary
Leading clinical evaluation for Trauma & Extremities implants, developing CEP/CER/SSCP/PMCF deliverables. Proven medical writing and clinical research experience required, regulated environment background preferred. International project scope within a global MedTech company.
Requirements
- University degree in life sciences, medical engineering, or equivalent
- Several years of clinical or academic research experience
- Proven medical or scientific writing experience
- Experience in data analysis and statistics
- Experience in a regulated environment preferred
- Knowledge of Clinical Evaluation regulations preferred
- Experience with clinical study design and analysis
- Independent work, decision-making, and project leadership
- Excellent communication and stakeholder-management skills
- Strong analytical mindset for scientific data
- Proactive, collaborative, and international teamwork skills
- Full professional English proficiency and German fluency
Tasks
- Lead the clinical evaluation process
- Develop and update CEP, CER, SSCP, and PMCF deliverables
- Perform complex literature reviews and analyze medical trends
- Develop sustainable literature search strategies
- Manage clinical evidence strategies during product development
- Align clinical goals with marketing and regulatory strategies
- Define and defend clinical strategies for international approvals
- Support new product development and post-market surveillance
- Provide expert clinical guidance to cross-functional teams
- Refine clinical evaluation methodologies to meet evolving regulations
Work Experience
- approx. 4 - 6 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- MEDDEV 2.7/1 Rev. 4
- EU MDR
- MDCG
- TGA
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Stryker 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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STStryker
Senior Clinical Affairs Specialist(m/w/x)
Freiburg im Breisgau
Full-timeOn-siteSenior
Nejo AI Summary
Leading clinical evaluation for Trauma & Extremities implants, developing CEP/CER/SSCP/PMCF deliverables. Proven medical writing and clinical research experience required, regulated environment background preferred. International project scope within a global MedTech company.
Requirements
- University degree in life sciences, medical engineering, or equivalent
- Several years of clinical or academic research experience
- Proven medical or scientific writing experience
- Experience in data analysis and statistics
- Experience in a regulated environment preferred
- Knowledge of Clinical Evaluation regulations preferred
- Experience with clinical study design and analysis
- Independent work, decision-making, and project leadership
- Excellent communication and stakeholder-management skills
- Strong analytical mindset for scientific data
- Proactive, collaborative, and international teamwork skills
- Full professional English proficiency and German fluency
Tasks
- Lead the clinical evaluation process
- Develop and update CEP, CER, SSCP, and PMCF deliverables
- Perform complex literature reviews and analyze medical trends
- Develop sustainable literature search strategies
- Manage clinical evidence strategies during product development
- Align clinical goals with marketing and regulatory strategies
- Define and defend clinical strategies for international approvals
- Support new product development and post-market surveillance
- Provide expert clinical guidance to cross-functional teams
- Refine clinical evaluation methodologies to meet evolving regulations
Work Experience
- approx. 4 - 6 years
Education
- Master's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- MEDDEV 2.7/1 Rev. 4
- EU MDR
- MDCG
- TGA
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Stryker 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
Stryker
Industry
Healthcare
Description
Das Unternehmen ist ein globales Medizintechnikunternehmen, das hochwertige Implantate für den Bereich Trauma & Extremities fertigt.
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