Regulatory Affairs Manager (m/w/d)

Niedersachsen

Medical Devices


My client located in Niedersachsen is a manufacturer of high-risk medical devices, and are currently searching for a new Regulatory Affairs Manager. The company is a highly innovative start-up, with just over 40 people currently working at the HQ in Germany, which is growing at a rapid rate due to continued success. This position would report directly to the Head of QM/RA, and would be working in close collaboration with the Quality Manager of the same level. For this reason, it would be an amazing time to join and become part of an award winning group, and to be have your say in bringing the company forward even further.

Your Role:

• Monitoring and implementing regulatory requirements both nationally and internationally
• Supervising and implementing nation and international regulatory approval and registration procedures
• Creating and updating legal requirements for the respective target markets, and to prepare country-specific submission documents
• Review and maintain existing registrations
• Communicating with external partners and regulatory authorities
• Supporting international sales in the qualification of distributors
• Supervising registration agencies / distributors during the country specific approval processes
• Monitoring international approval processes
• Organizing and implementing employee training when necessary

Your Profile:

• Successfully completed a degree in medical technology or comparable fields
• Several years of experience working in a regulatory affairs environment, ideally in medical technology
• Experience in the field of approvals for medical devices (class III) on an international scale
• Very strong knowledge of working with Office programs
• High level of commitment, reliability, and team spirit
• Fluency in both English and German