Would you like to become part of a dynamic, fast growing, International company in the highly innovative medical device industry?
We are currently searching for a Senior Regulatory Affairs Manager to join our forever growing team in Germany.
Key Responsibilities of the Senior Regulatory Affairs Manager:
• Responsible for the planning and support of European product rollouts
• Creation and review of product documentation according to the requirements of the relevant European guidelines for medical devices
• Market surveillance for our innovative new product line
• Creation and implementation of regulatory strategies for medical devices in the EMEA region
• Participation in the further development and maintenance of our QM system according to DIN EN ISO 13485
• Participation in the modelling of business processes in cooperation with the relevant departments
• Implementation of internal and supplier audits
• You coordinate regulatory projects and interact with third parties (e.g. consultants, CROs, distribution partner) concerning regulatory issues
• You develop regulatory strategies, participate in project teams and act as contact person with regards to regulatory requirements
Expectations for the Senior Regulatory Affairs Manager:
• University Degree in Science (Pharmacy, Medical Technology) or related degree/diploma in Science, Engineering, and/or Biotechnology. Degree in Engineering or equivalent technical experience
• Strong working experience with Regulatory Affairs in Medical Device/Pharmaceutical industry
• Experience with management of class I-III, Non-active and Active Medical Device Submissions Internationally
• Good German and English level in both writing and speaking.
• Great interpersonal and communication skills
If you believe this role could be of interest, or you would like to find out more, please apply or get in touch today.