Regulatory Affairs Manager (m/f/x) | Medical Devices | BW
In this position you will be mainly responsible for managing regulatory aspects of medical devices, focusing on compliance, regulations, and published guidance documents. Furthermore, you will coordinate and manage translations and approvals by local regulatory experts and work as part of projects teams to create launch materials for new products and indications.
What are your tasks as "Regulatory Affairs Manager (m/f/x)"?
- Planning, preparation and maintenance of the technical documentation for medical devices in accordance with Regulation (EU) 2017/745 (MDR)
- International product approvals
- Development of approval strategies for new medical devices
- Close cooperation with the product management, R&D and quality management departments
- Contact with professional circles at home and abroad and participation in specialist events
What requirements do you need for "Regulatory Affairs Manager (m/f/x)"?
- at least 2 years experience in Regulatory Affairs
- Bacherol or Mster of Science or Chemistry or relevant qualification
- knowledge of MDR in theory and practice
- knowledge of technical documentation for medical devices
- Experience in the areas of quality management according to DIN EN ISO 13485
- fleunt in English and German, other languages are a plus
What does the position as "Regulatory Affairs Manager (m/f/x)"? offer to you?
- Operate in an international, fast-growing company that shows high appreciation for commitment, performance and personality
- home office twice a week
- Flexible work hours
- 30 vacation days & additional compensation days
About the client?
Our client is a researcher, developer and manufacturer of validated medical devices and services. They are an active company with a value-oriented corporate culture. The complete solutions in the areas of screening, diagnostics, and follow-up management, that they offered, make them a market leader in Medical Device area.
Are you interested in such company? Then you should apply now! If you would like to receive Information, I would be happy to let you more about it and other opportunities:
Contact for application:
- E-Mail: firstname.lastname@example.org
- Tel: +49 (0)89 / 26200311
- LinkedIn: https://www.linkedin.com/in/marianna-furchÃ¬-90872750/