Head of QA/RA

We have a current opportunity for a Head of QA/RA on a permanent basis. The position will be based in Oberhonnefeld-Gierend. For further information about this position please apply.

Job Summary: The Head of Quality and Regulatory Affairs will oversee and manage all quality and regulatory functions for Class I and Class II medical devices. This role ensures compliance with relevant regulations, standards, and guidelines, while driving continuous improvement in quality management systems.

Key Responsibilities:

1. Quality Management:

   • Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485 and other relevant standards.
   • Ensure compliance with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).
   • Lead internal and external audits, including those by regulatory bodies and notified bodies.
   • Oversee the management of non-conformities, CAPAs (Corrective and Preventive Actions), and continuous improvement initiatives.
   • Ensure product quality and safety through rigorous testing, validation, and documentation processes.

2. Regulatory Affairs:

   • Develop and execute regulatory strategies to ensure timely product approvals and market access.
   • Prepare and submit regulatory submissions, including 510(k) notifications, to relevant authorities (e.g., FDA, EU MDR).
   • Monitor and interpret regulatory changes and ensure the company remains compliant with all applicable regulations.
   • Provide regulatory guidance and support to cross-functional teams, including R&D, manufacturing, and marketing.
   • Manage post-market surveillance activities, including adverse event reporting and product recalls.

3. Leadership and Management:

   • Lead and mentor the Quality and Regulatory Affairs team, fostering a culture of excellence and continuous improvement.
   • Set departmental goals and objectives, and monitor performance against these targets.
   • Collaborate with other departments to ensure alignment and integration of quality and regulatory activities.
   • Represent the company in regulatory inspections and audits, and communicate effectively with regulatory authorities.

4. Documentation and Reporting:

   • Ensure accurate and timely documentation of all quality and regulatory activities.
   • Prepare and present reports on quality and regulatory performance to senior management.
   • Maintain up-to-date records of regulatory submissions, approvals, and correspondence.

Qualifications:

• Bachelor's degree in a relevant field (e.g., Engineering, Life Sciences, Quality Management).
• Minimum of 15+ years of experience in quality and regulatory roles within the medical device industry, with a focus on Class I and Class II products.
• In-depth knowledge of ISO 13485, FDA regulations, EU MDR, and other relevant standards and guidelines.
• Proven track record of successful regulatory submissions and product approvals.
• Strong leadership and team management skills.
• Excellent communication and interpersonal skills.
• Ability to work effectively in a fast-paced, dynamic environment.

Preferred Qualifications:

• Certification in quality management (e.g., ASQ Certified Quality Manager).
• Experience with international regulatory submissions and approvals.