Mackenzie Stuart is currently partnered with a Market leader in the Medical Devices industry. They are currently in a period of continued growth and are now looking to expand their Regulatory team. As a result they are looking for Regulatory Affairs specialist and Senior Specialists for their Germany organisation.
- Ensure compliance to all US, EU and international requirements and regarding submissions and other requirements for market approval of medical devices/combination products.
- Coordinate with the FDA, Notified Bodies and other regulatory agencies on submissions, approvals or other issues.
- Support R&D, marketing and manufacturing teams in regulatory assessment of proposed changes or product transfers.
- Liaise with various departments on project from the initial stages through securing government approvals and project requiring Regulatory Affairs support.
- Fluent in Spoken & Written German & English
- 2+ Years’ experience in Regulatory Affairs in Medical Devices
- Orthopaedics experience preferred
- Experience with MDD, EU regulatory bodies, CE mark
- 510k submission experience highly desired
This is a fantastic opportunity to work with a Market leading Medical Devices Organisation. If you feel you would be suitable for the role, please apply.
Due to the high volume of applications we are unable to notify unsuccessful applicants. If you have not been notified of the outcome of your application within one week of the closing date, please assume your application has been unsuccessful on this occasion.
Job Reference: CA-MD-336
€60,000 - 70,000