Medartis AG
Basel
Regulatory Affairs Manager 100%
- 05 November 2026
- 100%
- Permanent position
- Basel
Job summary
Join Medartis as a Regulatory Affairs Manager in a dynamic team. Enjoy a supportive work environment with growth opportunities.
Tasks
- Ensure compliance with regulations for medical device development and market launch.
- Develop regulatory strategies for various projects and maintain documentation.
- Coordinate international approvals and serve as liaison with authorities.
Skills
- Degree in engineering, life sciences, or law; 3+ years in regulatory affairs.
- Strong knowledge of MDR, ISO 13485, and FDA regulations.
- Excellent communication skills in German and English.
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About the job
Regulatory Affairs Manager 100%
Your area of responsibility
- Ensuring regulatory requirements for the development, manufacture and market launch of medical devices
- Development of regulatory strategies within the framework of development projects
- Creation and maintenance of technical and regulatory documentation as well as conducting CE conformity assessment procedures
- Planning and coordination of international approvals and registrations as well as maintenance of existing approvals
- Contact person for authorities and notified bodies as well as support during audits and inspections
- Professional advice to various stakeholders in the preparation of technical documentation for CE and FDA approvals
- Conducting product file reviews (DHF/DHR) and design reviews
- Assessment of changes regarding reporting obligations and their implementation in the PLM system
- Participation in product risk management according to ISO 14971, especially in design FMEAs
- Support and management of product phase-outs
- Standard management as well as evaluation of international regulatory and normative requirements and their implementation in regulatory processes and templates
- Management of regulatory and quality-relevant projects as well as conducting training sessions
Your qualifications
- Completed studies in engineering sciences, medical technology, life sciences, law or a comparable field
- At least 3 years of professional experience in the regulatory field of medical technology
- Sound knowledge of MDR (EU) 2017/745, ISO 13485 and ISO 14971; knowledge of FDA requirements (21 CFR 820)
- Experience in technical documentation and approval procedures
- Very good German and English skills, both written and spoken
- Precise, structured and solution-oriented working style with an eye for detail
- Enjoyment in dealing with people, good communication skills and high initiative
What we offer
We offer you a responsible and varied role in Regulatory Affairs within a growing, international company, with opportunities for professional development.
Perhaps you will soon help shape our success story with your passion and expertise.
About Medartis
At Medartis, we combine innovative solutions with qualified professionals to be the preferred provider in orthopaedics. The Medartis Group was founded in 1997 and is headquartered in Basel, Switzerland. It is one of the world’s leading manufacturers and suppliers of medical technology for the surgical treatment of bone fractures of the upper and lower extremities as well as in the cranio-maxillofacial area. The company employs around 1,400 people at 13 locations and sells its products in over 50 countries worldwide.
For more information, please visit our homepage www.medartis.com.
We look forward to receiving your complete online application.
We look forward to receiving your complete online application.
