KLS Martin Group
Clinical Affairs Specialist(m/w/x)
Full-timeWith HomeofficeExperienced
Mühlheim an der Donau, Tuttlingen, Freiburg im Breisgau, Fridingen an der Donau
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STStryker Leibinger GmbH & Co. KG
(Senior) Staff Clinical Evaluation Specialist(m/w/x)
Freiburg im Breisgau
Full-timeWith Home OfficeExperienced
Nejo AI Summary
Managing clinical evaluation projects for new medical devices, aligning evidence strategies with regulatory claims. Master's degree and 4+ years of relevant experience required. Focus on ISO 13485 and MDR compliance.
Requirements
- Master of Science degree in health/science-related field
- Doctorate degree in health/science-related field preferred
- 4+ years research, clinical, quality, or regulatory affairs experience
- 3 years experience writing clinical evaluations for medical devices
- Interpreting regulations, standards, and product information
- Applying regulations to develop market access strategy
- Understanding and communicating new medical topics
- Successful track record managing complex projects
- Effective work with cross-functional internal and external stakeholders
- Excellent scientific and medical writing skills
- Strong communication skills
- Strong project management skills
- Strong influencing skills
- Strong negotiation skills
- Effective communication up/down and across organization levels
- Motivated self-starter
- Ability to work with minimal supervision
- Ability to make independent decisions with limited information
- Strong planning skills
- Strong organizational skills
- Attention to quality
- Ability to adapt to changing priorities
- Analytical capabilities
- Problem-solving capabilities
- Strong technical aptitude
- Ability to draw insights from data quickly
- Ability to define executable actions
- Ability to build strong relationships
- Fostering open communication, respect, and trust
Tasks
- Manage clinical evaluation projects
- Develop evidence strategies for new products
- Align with claims, regulatory, clinical research, and preclinical testing
- Draft and update regulatory documents
- Prepare submissions, annual reports, clinical evaluations, and safety summaries
- Present clinical information clearly and accurately
- Design literature search strategies
- Perform systematic reviews of clinical data
- Analyze medical and scientific trends
- Form and justify benefit-risk conclusions
- Negotiate with regulators on clinical evidence
- Drive evidence communication with stakeholders
- Translate complex information for various audiences
- Identify knowledge gaps in clinical research
- Develop pre-clinical and clinical data collection strategies
- Support new product development
- Develop intended use and indication statements
- Create risk files and product claims
- Ensure continued product availability
- Translate clinical data into new claims
- Review marketing collateral for accuracy
- Proactively manage project scheduling and resources
- Implement efficiency strategies
- Resolve document content issues
- Manage cross-functional review processes
- Support innovation and operational excellence
- Set direction for internal procedures
- Serve as a subject matter expert
- Mentor and direct team members
Work Experience
- 3 years
Education
- Master's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Stryker Leibinger GmbH & Co. KG 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 Leibinger GmbH & Co. KG
(Senior) Staff Clinical Evaluation Specialist(m/w/x)
Freiburg im Breisgau
Full-timeWith Home OfficeExperienced
Nejo AI Summary
Managing clinical evaluation projects for new medical devices, aligning evidence strategies with regulatory claims. Master's degree and 4+ years of relevant experience required. Focus on ISO 13485 and MDR compliance.
Requirements
- Master of Science degree in health/science-related field
- Doctorate degree in health/science-related field preferred
- 4+ years research, clinical, quality, or regulatory affairs experience
- 3 years experience writing clinical evaluations for medical devices
- Interpreting regulations, standards, and product information
- Applying regulations to develop market access strategy
- Understanding and communicating new medical topics
- Successful track record managing complex projects
- Effective work with cross-functional internal and external stakeholders
- Excellent scientific and medical writing skills
- Strong communication skills
- Strong project management skills
- Strong influencing skills
- Strong negotiation skills
- Effective communication up/down and across organization levels
- Motivated self-starter
- Ability to work with minimal supervision
- Ability to make independent decisions with limited information
- Strong planning skills
- Strong organizational skills
- Attention to quality
- Ability to adapt to changing priorities
- Analytical capabilities
- Problem-solving capabilities
- Strong technical aptitude
- Ability to draw insights from data quickly
- Ability to define executable actions
- Ability to build strong relationships
- Fostering open communication, respect, and trust
Tasks
- Manage clinical evaluation projects
- Develop evidence strategies for new products
- Align with claims, regulatory, clinical research, and preclinical testing
- Draft and update regulatory documents
- Prepare submissions, annual reports, clinical evaluations, and safety summaries
- Present clinical information clearly and accurately
- Design literature search strategies
- Perform systematic reviews of clinical data
- Analyze medical and scientific trends
- Form and justify benefit-risk conclusions
- Negotiate with regulators on clinical evidence
- Drive evidence communication with stakeholders
- Translate complex information for various audiences
- Identify knowledge gaps in clinical research
- Develop pre-clinical and clinical data collection strategies
- Support new product development
- Develop intended use and indication statements
- Create risk files and product claims
- Ensure continued product availability
- Translate clinical data into new claims
- Review marketing collateral for accuracy
- Proactively manage project scheduling and resources
- Implement efficiency strategies
- Resolve document content issues
- Manage cross-functional review processes
- Support innovation and operational excellence
- Set direction for internal procedures
- Serve as a subject matter expert
- Mentor and direct team members
Work Experience
- 3 years
Education
- Master's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Stryker Leibinger GmbH & Co. KG 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 Leibinger GmbH & Co. KG
Industry
Healthcare
Description
Das Unternehmen ist auf die Herstellung von resorbierbaren Implantaten in der Medizintechnik spezialisiert.
Not a perfect match?
- KLS Martin Group
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