Regulatory Affairs Manager

We are currently recruiting for a Regulatory Affairs Manager for a global company in Berlin focused on cancer treatment. The position has up to 50% remote flexibility and gives an opportunity to work with high-risk class products that help people by providing affordable healthcare with innovative technology. 


About the opportunity:

• Standardization of technical product documentation, usage guidelines, and markings

• Participation in the risk management activities

• Establishing and maintaining relationships with both domestic and international licensing bodies

• Evaluation and notification of product changes to approval bodies

• Determination of laws, rules, and regulation

• Carrying out specific assignments as directed by the supervisor

• Creation and maintenance of the technical documentation for medical devices in accordance with international (Europe, USA) requirements

• Coordination of cross-site approval initiatives

• Creation and upkeep of documentation for the official approval of products in German and English

• Responsible participation in the maintenance and extension of quality management

• Collaborative culture with no-micromanagement

Requirements:

• Completed studies in Technical/Economic or Scientific studies

• Good knowledge of MS office

• Ability to work in a team

• Previous experience working in the approval of medical devices

• Willingness to learn

• Excellent skills in German and English (Both spoken and written)

• Great communication skills

If this sounds like you, please do not hesitate and send the application, if you do not have your current CV updated you can get in contact via LinkedIn.
If you have any questions regarding the position, please contact:
Dominika Wyrwinska
dominika.wyrwinska@adaptivelifescience.com


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