We are a growing medical device company operating in global markets, committed to the highest standards of quality, innovation, and regulatory compliance.
We are seeking an experienced and highly motivated QA Manager to lead our Quality Assurance and Regulatory Affairs activities and ensure full compliance with international standards.
Key Responsibilities:
- Act as the Management Representative for the Quality Management System (QMS)
- Lead the implementation, maintenance, and continuous improvement of the QMS in accordance with ISO 13485, FDA, and MDR requirements
- Ensure full compliance with international regulatory standards, including EU MDR, FDA, and CE marking requirements
- Oversee quality processes, including internal and external audits, cleanroom monitoring in accordance with ISO 14644, and process control
- Manage customer complaints and post-market feedback (PMF), including CAPA processes
- Handle non-conformities and drive continuous improvement initiatives across the organization
- Maintain and update quality procedures and work instructions
- Lead regulatory activities, including submissions, responses, and ongoing compliance across global markets
- Manage relationships with Notified Bodies, regulatory authorities, and external consultants
- Oversee and approve subcontractors and suppliers, including quality system evaluations
- Conduct training programs to ensure company-wide QMS awareness and compliance
- Report regularly to senior management on QMS performance and regulatory status
- Work closely with cross-functional teams, including R&D, Operations, Marketing, and Sales
Additional Details:
Full-time position, on-site (non-hybrid).
Requirements: - Bachelors degree in Science, Engineering, or a related field
- Minimum 5 years of experience managing QMS in the medical device industry
- Minimum 5 years of experience in regulatory affairs (EU MDR, FDA)
- Strong knowledge of ISO 13485 and global regulatory requirements
- Experience working with Notified Bodies and regulatory authorities
- Excellent analytical, organizational, and communication skills
- Ability to lead processes and work effectively across multiple departments
- Fluent in English (written and spoken) - mandatory
Advantages:
- Experience with Class II/III medical devices
- Experience working with BSI or other Notified Bodies
- Experience with global registrations (LATAM, Asia, etc.)
- Experience in audit preparation and technical file submissions
This position is open to all candidates.