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.
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