Basel
10 hours ago
Regulatory Affairs Manager 100%
- 17 April 2026
- 100%
- Permanent position
- Basel
Job summary
Join Medartis as a Regulatory Affairs Manager in a dynamic team. Drive compliance and innovation in medical device development.
Tasks
- Ensure adherence to regulatory requirements for medical devices.
- Maintain and update regulatory documentation for compliance.
- Support product approvals and liaise with regulatory agencies.
Skills
- Degree in Life Science, Business, or related fields; experience in medical tech.
- Strong organizational skills with attention to detail.
- Proficient in Microsoft Office and good communication skills.
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About the job
To support our team, we are looking for a committed individual as
Regulatory Affairs Manager 100%
Your area of responsibility
- Ensuring compliance with regulatory requirements for the development, manufacturing, and market launch of medical devices
- Maintaining and updating regulatory documentation to ensure compliance
- Contact person for authorities/agencies for product approval
- Professional support and advice to development engineers and other stakeholders in the preparation and development of the required technical documentation for CE / FDA approval
- Conducting product file reviews (DHF/DHR) and design reviews
- Evaluating changes regarding reporting obligations and implementing these changes in the PLM system
- Developing regulatory strategies within the framework of development projects
- Maintaining and creating regulatory processes and template documents
- Accompanying and managing product phase-outs
- Conducting CE conformity assessment procedures
- Carrying out regulatory and quality-relevant projects as well as training
Your qualifications
- Completed studies in the field of Life Science, Business Administration, Statistics, etc.
- Several years of professional experience in medical technology or pharmaceuticals
- Knowledge and experience in the field of technical documentation and/or document control
- Good German and English skills, both spoken and written
- Confident handling of Microsoft Office Suite or related software
- Strong organizational skills and an eye for detail
- Enjoy working with people and good communication skills
- Precise, efficient, and responsible way of working
- Ability to work proactively and solution-oriented in a dynamic environment
- High level of motivation and initiative
What we offerWe offer you a responsible and varied activity in the field of Regulatory Affairs in a growing and international company.
Perhaps you will soon shape our success story with your passion and skills.
About MedartisAt Medartis, we combine innovative solutions with qualified professionals to be the preferred provider in orthopedics. 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.
Medartis
Human Resources
jobs@medartis.com
www.medartis.com
Human Resources
jobs@medartis.com
www.medartis.com
