Director of Regulatory Affairs & Quality

Are you passionate about improving healthcare outcomes and ensuring compliance with regulatory standards? Do you have experience leading quality assurance processes in the medical device industry? Philips is seeking a highly motivated and driven individual to join our team as the Director of Regulatory Affairs & Quality. In this role, you will be responsible for developing and implementing strategies to ensure compliance with regulations and quality standards for our products. We are looking for a dynamic leader with extensive knowledge of regulatory requirements, strong communication skills, and a proven track record of success in quality management. If you are ready to make a meaningful impact in the healthcare industry, we encourage you to apply for this exciting opportunity.

1. Develop and implement strategies to ensure compliance with regulatory standards and quality requirements for medical device products.
2. Stay up-to-date with relevant regulations and industry standards and communicate any changes or updates to the company.
3. Lead and manage the quality assurance team, providing guidance, training, and support as needed.
4. Oversee the development and maintenance of quality management systems, including document control, risk management, and corrective and preventive actions.
5. Conduct internal audits to assess compliance with regulations and identify areas for improvement.
6. Collaborate with cross-functional teams to ensure quality and regulatory requirements are addressed throughout the product lifecycle.
7. Prepare and submit regulatory submissions, including 510(k) applications and technical files, in a timely and accurate manner.
8. Serve as the primary point of contact for regulatory agencies and participate in regulatory inspections and audits.
9. Communicate with key stakeholders, including customers and suppliers, regarding regulatory and quality issues.
10. Monitor and report on key quality metrics, identifying trends and implementing corrective actions as necessary.
11. Develop and maintain strong relationships with regulatory bodies and industry organizations.
12. Spearhead continuous improvement initiatives to enhance quality and compliance processes.
13. Stay informed about industry best practices and make recommendations for process improvements.
14. Ensure all products meet international regulatory requirements for global distribution.
15. Provide leadership and mentorship to team members, fostering a culture of continuous learning and development.

According to JobzMall, the average salary range for a Director of Regulatory Affairs & Quality in Nashville, TN, USA is between $140,000 to $190,000 per year.

Royal Philips is a health technology company focused on improving people's health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. The company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care.