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)
- Regulatory review and evaluation of product changes
- Participation in the development of the product creation and change process
- Close cooperation with the quality management department
What requirements do you need for "Regulatory Affairs Manager (m/f/x)"?
- 2+ years experience in Regulatory Affairs
- Bacherol or Master of Science or relevant qualification
- knowledge of MDR in theory and practice
- knowledge of technical documentation and EU regulation
- fluent in English and German
What does the position as "Regulatory Affairs Manager (m/f/x)"? offer to you?
- Operate in an international, fast-growing company
- Individual induction and further training opportunities
- Modern workplace equipment
- home office 2 days per 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/