QA&RA MANAGER

We are seeking an experienced QA/RA Manager to lead the company’s Quality Assurance and Regulatory Affairs activities. This is a hands-on leadership role responsible for maintaining and advancing the company’s Quality Management System while driving regulatory strategy, including the IVDR transition and future FDA submissions.

The QA/RA Manager will work closely with company leadership, external consultants, and cross-functional teams to ensure compliance with global regulatory standards and support the company’s growth into international markets. This role offers a unique opportunity to build and lead the QA/RA function in a growing medical device company, shaping regulatory strategy and quality systems as the company expands globally.

This role reports directly to the CEO.

Roles & Responsibilities:

Quality Management System %28QMS%29

· Lead all QA activities in the company.

· Maintain the company ISO 13485 certified QMS. Prepare and support ISO certification audits and external inspections based on IVDR requirements.

· Perform annual updates of the Quality Manual.

· Conduct annual management review and maintain quality metrics. Manage and close CAPA, MRB and ECO processes.

· Oversee equipment calibration program.

· Maintain and update risk management documentation %28ISO 14971%29.

· Maintain supplier qualification records and supplier performance logs.

· Ensure continuous QMS improvement and documentation contorl and updates.

· Coordinate all customer complaint aspects in the company.

· Support manufacturing activities, review batch records, perform a final inspection, and approve finished product release. Perform quality audits for critical suppliers.

· Coordinator of training based on training requirements, training on all quality aspects, and defining annual training plan.

· Support the R&D activities, such as design validations and reviews and process validations.

Regulatory Affairs

· Lead and manage the company’s IVDR submission and transition activities

including readiness activities and project milestones.

· Manage communication with Notified Bodies and regulatory consultants