Employee in Quality Management and/or Regulatory Affairs (m/f/d)

As a professional QM/RA associate, you will be responsible for the following tasks:

• Support and collaborate across all areas of Quality Management (QM).
• Ongoing control, improvement, and optimization of quality management processes and standards.
• Assist in creating and reviewing deviation reports, risk management plans, and CAPA (Corrective and Preventive Actions), ensuring thorough monitoring of corrective actions.
• Ensure the implementation and monitoring of regulatory requirements for medical devices.
• Assist with international product certifications and approvals.
• Liaise with regulatory bodies and authorities, including correspondence with notified bodies (globally).
• Support clinical evaluations, ensuring that medical devices meet clinical safety and performance requirements in accordance with regulatory standards.
• Participate in post-market surveillance activities, including monitoring product performance in the market and managing feedback loops to continuously improve device safety and effectiveness.
• Support internal and external audits as well as supplier audits.
• Assist R&D with documentation and support the development process.