Intuitive
Regulatory Affairs Specialist(m/w/x)
Full-timeOn-siteExperienced
Aubonne
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HAHaemonetics S.A.
Scientific Affairs Specialist(m/w/x)
Signy-Avenex
Full-timeOn-siteExperienced
Nejo AI Summary
Preparing Clinical Evaluation Reports and systematic literature reviews for regulatory compliance at a medical device and diagnostics company. 2-5 years MedTech/IVD/Pharma experience with scientific writing and regulatory documentation skills required. Work in a collaborative cross-functional team.
Requirements
- Bachelor’s degree in Life Sciences, Medicine, Pharmacy, or related field
- 2–5 years’ experience in MedTech, IVD, or Pharma
- Experience in scientific writing, literature reviews, and regulatory/clinical documentation
- Demonstrated ability in scientific communication and stakeholder engagement
- Knowledge of product development and regulatory environments
- Experience working cross-functionally with R&D, Clinical, Medical, Quality, Regulatory, and Marketing teams
- Strong analytical, project management, and organisational skills
- Excellent written and verbal communication skills in English
- Ability to interpret complex data and contribute to scientific excellence
Tasks
- Assist in implementing and updating the scientific strategy for assigned products
- Monitor and apply relevant regulatory requirements to scientific programs and documentation
- Prepare and update Clinical Evaluation Reports (CERs) and Performance Evaluation Reports (PERs)
- Conduct systematic literature reviews and post-market clinical follow-ups
- Collaborate with cross-functional teams to maintain scientific standards
- Coordinate with vendors to ensure timely delivery of outsourced projects
- Contribute to the design and reporting of clinical studies and real-world evidence projects
- Assist in developing publication plans and translating scientific data for various audiences
- Support the dissemination of scientific insights through publications and presentations
- Review marketing materials and monitor scientific developments for product lifecycle management
- Provide scientific data and literature summaries for product launches and regulatory submissions
Work Experience
- 2 - 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- FDA
- EMA
- MDR
- IVDR
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Haemonetics S.A. 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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HAHaemonetics S.A.
Scientific Affairs Specialist(m/w/x)
Signy-Avenex
Full-timeOn-siteExperienced
Nejo AI Summary
Preparing Clinical Evaluation Reports and systematic literature reviews for regulatory compliance at a medical device and diagnostics company. 2-5 years MedTech/IVD/Pharma experience with scientific writing and regulatory documentation skills required. Work in a collaborative cross-functional team.
Requirements
- Bachelor’s degree in Life Sciences, Medicine, Pharmacy, or related field
- 2–5 years’ experience in MedTech, IVD, or Pharma
- Experience in scientific writing, literature reviews, and regulatory/clinical documentation
- Demonstrated ability in scientific communication and stakeholder engagement
- Knowledge of product development and regulatory environments
- Experience working cross-functionally with R&D, Clinical, Medical, Quality, Regulatory, and Marketing teams
- Strong analytical, project management, and organisational skills
- Excellent written and verbal communication skills in English
- Ability to interpret complex data and contribute to scientific excellence
Tasks
- Assist in implementing and updating the scientific strategy for assigned products
- Monitor and apply relevant regulatory requirements to scientific programs and documentation
- Prepare and update Clinical Evaluation Reports (CERs) and Performance Evaluation Reports (PERs)
- Conduct systematic literature reviews and post-market clinical follow-ups
- Collaborate with cross-functional teams to maintain scientific standards
- Coordinate with vendors to ensure timely delivery of outsourced projects
- Contribute to the design and reporting of clinical studies and real-world evidence projects
- Assist in developing publication plans and translating scientific data for various audiences
- Support the dissemination of scientific insights through publications and presentations
- Review marketing materials and monitor scientific developments for product lifecycle management
- Provide scientific data and literature summaries for product launches and regulatory submissions
Work Experience
- 2 - 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- FDA
- EMA
- MDR
- IVDR
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Haemonetics S.A. 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
Haemonetics S.A.
Industry
Healthcare
Description
The company supports scientific direction through product development, regulatory compliance, and innovation.
Not a perfect match?
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