JR Manager Regulatory Affairs OPM
Entry (0-2 years), Middle (2-5 years)
English - advanced, French - advanced
This job is inactive, but you can still send your resume to the company
B. Braun is a major international company and a leading provider of the global health care market. More than 900 employees develop, produce and sell high-quality products for worldwide use.
In our B. Braun Out Patient Market (OPM) division we develop and manufacture products for Diabetes, Stoma, Urinary and Wound Care as well as for Infection Control. Products are manufacutered at different sites in Europe and sold globally.
The scope of duties includes all necessary activities to provide new and update Technical Files according the new Medical Device Regulations.
Your main tasks:
- Preparation and maintenance of Export registration files on the basis of the CE marking file for assigned products groups
- Support preparation of documentation of the CE marking file in co-operation with Global Regulatory Affairs
- Preparation of documentation for customer specific requests (tender, etc.) in co-operation with Global Regulatory Affairs
- Update databases
- Cooperation with the departments of the company in the field of regulatory activities (labelling, marketing materials, clinical evaluation report, etc.)
- Implementation of other tasks arising from the current needs of the Regulatory Affairs Department
- Supports task forces and specific RA related projects
- Assure lessons-learned procedures
- Safeguarding/Adherence of Compliance Regulation “Code of Conduct“
- University degree (pharmacy, medical engineering, chemistry, biochemistry, biology or medicine)
- Experience in the medical devices documentation and regulatory affairs field
- Very good English skills (French would be an advantage)
- Good PC Knowledge (MS Office, Adobe Professional, Outlook)
- Analytical and structured way of thinking and working
- Organized with good communication skills,
- Willing to travel internationally
- Team work skills
Become part of a corporate culture that actively promotes constructive exchanges between colleagues, customers and partners. Work with us to improve people's lives in the long term. We can offer you interesting, varied tasks and excellent opportunities for advancement, as well as an attractive salary and benefits, all within a dynamic family-owned company.