Sr. Regulatory Affairs Manager (483413/002) Tuttlingen, Germany

Sr. Manager of Regulatory Affairs

Job type: Permanent
Location: Tuttlingen, Germany
 
A mid-sized global, amazingly innovative Medical Device manufacturer is currently seeking to hire a Sr. Manager of Regulatory Affairs to join their growing team in Tuttlingen. You will be able to make an immediate impact on both their American and European operations as the company continues to prepare for the MDR.

Key responsibilities of the Sr. Manager of Regulatory Affairs include:

• Perform regulatory audits of Clients, as well as evaluations of regulatory submissions which include Technical File Review, according to EU and FDA directives.
• Help with the transition from the MDD to MDR
• Manage up to 4 people in the department

 

Key requirements of the Sr. Manager of Regulatory Affairs include:

• The ideal candidate should have a strong background in the Medical Device industry.
• Direct involvement in Quality Management System (QMS)/Technical Documentation of a Medical Manufacturer according to international Standards such as ISO 13485
• University degree in Engineering or Sciences

 

Benefits:

• 1 month bonus Salary
• Health and Dental insurance
• Food and travel incentive
• Wellness programmes promoted internally by the company

 
If you are interested in the
Sr. Manager of Regulatory Affairs
position, apply online today or contact Sam Shew for more information.
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