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

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Join us and lead your own success story with us.

Darum lohnt es sich

You Are Here • Schoelly • Career • Job Offerings 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.

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 • Hansefit and Bikeleasing Your Contact Andrea Hauschel Senior Human Resources Specialist +49 7666 908-0 working(at)schoelly.de • Share page: • Xing • LinkedIn • Twitter • Facebook • Print page: 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.