Product Manager Medical Scientific Affairs (m/f/d)

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SCHÖLLY has been developing endoscopic visualization systems that are used for the benefit of people for 50 years.

Customer-focused, cooperative, imaginative, humane, competent and value-creating - these are the values that define us and that give our teams room to grow and thrive.

Join us and lead your own success story with us.

Your Contact

Andrea Hauschel

Senior Human Resources Specialist

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working(at)schoelly.de

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Product Manager Medical Scientific Affairs (m/f/d)

Your responsibilities

• You are responsible for the authorship and scientific accountability of MSA-relevant documents, particularly Clinical Evaluation Reports (CER), PMCF, and SSCP documents.
• You are responsible for the creation, review, and maintenance of clinically scientific and regulatory content as part of technical documentation.
• You oversee the assurance of document quality through structured reviews, critical evaluation of scientific data, and cross-functional collaboration.
• You are responsible for templates, processes, and training related to MSA documentation, including Clinical Evaluation Reports (CER), PMCF, SSCP, Usability Engineering Files, Device Descriptions, Design Validation, and Performance Validation.

Your profile

• You hold a degree in Medicine, Life Sciences, Natural Sciences, Biomedical Engineering, or a comparable field of study.
• You possess in-depth knowledge of technical documentation and product dossiers required for medical device approvals under MDR and FDA regulations.
• You have experience in the preparation and review of regulatory submission documents for medical devices in compliance with MDR and FDA requirements.
• An analytical and detail-oriented working style, strong communication and teamwork skills, and the ability to translate complex scientific and regulatory information into clear, audience-appropriate content complete your profile.

What we offer

• Opportunities for development in a flexible company with a strong group in the background
• Motivated colleagues, flat hierarchies, short decision-making processes and a spirit of partnership
• Performance-related remuneration, flexible working hours with home office options, an attractively subsidized pension scheme and favorable special conditions for a wide range of private insurance policies
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