Alina Richters

Regulatory Affairs Operatons Manager at Paul Hartmann AG

Alina Richters is an experienced professional in Regulatory Affairs and Quality Management, currently serving as the Regulatory Affairs Operations Manager at HARTMANN GROUP since March 2022. In this role, Alina collaborates with Development and Marketing to oversee development projects from a regulatory perspective and coordinates internal functions to enhance regulatory compliance and documentation. Prior experience includes working as a Quality Engineer (EU MDR) at Stryker, where Alina focused on technical documentation, regulatory implementation, and collaboration on EU MDR projects. Previous roles involved process optimization at Olympus Surgical Technologies Europe and preparation of Clinical Evaluation Reports at Olympus Europa SE & Co. KG. Alina holds a Master of Science and a Bachelor of Science in Biomedical Engineering from Hamburg University of Applied Sciences.

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