Jobbeschreibung
The bess group is a medium-sized, owner-managed business with an international presence, manufacturing sites in Berlin (Germany), the United States and France, and around 140 members of staff.
As manufacturers and distributors of implants, instruments and innovative device systems, we serve clients across the fields of ENT, head and neck surgery, pulmonology and gastroenterology. For over 30 years, we have also been providing custom-made devices and supporting medical innovation, building a reputation as highly competent and valued partners. Our brands boast a firmly established international presence; many have been identified as the gold standard in the literature.
Our mission is to develop, manufacture and provide life science products that deliver the best possible treatment outcomes for all patients. It is our ambition to maintain our levels of quality, safety and efficacy to such a high standard that members of staff would not hesitate either to use our products for themselves or to recommend them for a loved one.
We are currently looking for a
Clinical Affairs Manager (m/w/d)
to expand and strengthen our Medical Affairs team. The role is full-time or part-time, and based at our headquarters in Berlin.
- Plan, prepare and update clinical evaluations and periodic safety update reports for medical devices (in English)
- Conduct literature searches and evaluations
- Support the planning and coordination of preclinical and clinical studies for device approval and Post-Market Surveillance
- Provide support to the risk management process by contributing to risk analyses and the evaluation of residual risks
- Work in close collaboration with R&D, Product Management and Regulatory Affairs, supporting R&D projects and life cycle management
- A Bachelor's degree (or higher) in a life sciences field
- Professional experience in clinical research or other relevant experience
- Fluent in English (minimum C1 level); international experience an advantage
- Strong skills in and enjoyment of scientific writing
- A meticulous and efficient work style
- Effective time management and ability to work in a team
- German at B2 level or higher
We offer a permanent position boasting interesting and varied tasks and a high degree of autonomy. You will be working in an innovative, international medical devices company with a promising future. In addition to flexible hours and occasional working from home, we offer a team-oriented approach to work, flat hierarchies and room for professional development. You will undergo a robust and comprehensive onboarding and induction program.
In addition to a good IT infrastructure, we also offer Nespresso, tea, water and (oat) milk – and an annual summer party.
You can reach us easily by bus, bike or car. Bicycle parking is available on site, and plenty of car parking spaces can be found in the neighboring streets.
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