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 & RA Director 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.