Principal Regulatory Affairs Specialist

Welcome to Philips, a global leader in healthcare technology. We are currently seeking a dynamic and experienced Principal Regulatory Affairs Specialist to join our team. As a Principal Regulatory Affairs Specialist, you will play a critical role in ensuring compliance with regulatory requirements and supporting the development and launch of innovative medical devices. We are looking for a highly skilled individual with a deep understanding of medical device regulations, strong problem-solving abilities, and excellent communication skills. If you are passionate about making a positive impact in healthcare and have the qualifications we are looking for, we encourage you to apply for this exciting opportunity.

1. Develop and maintain a thorough understanding of global medical device regulations and standards.
2. Ensure compliance with all applicable regulatory requirements and standards for the development and commercialization of medical devices.
3. Provide regulatory guidance and support to cross-functional teams throughout the product development process.
4. Collaborate with internal and external stakeholders to gather necessary information for regulatory submissions and approvals.
5. Prepare and submit regulatory filings and registrations to regulatory agencies.
6. Monitor and track changes in regulations and communicate updates to relevant teams.
7. Review and approve product labeling, advertising, and promotional materials to ensure compliance with applicable regulations.
8. Participate in internal and external audits and inspections, and provide support for corrective and preventive actions.
9. Identify and assess potential regulatory risks and develop strategies to mitigate them.
10. Serve as the primary point of contact with regulatory agencies and respond to any inquiries or requests for additional information.
11. Train and educate team members on regulatory requirements and changes.
12. Stay up-to-date on industry trends and best practices in regulatory affairs.
13. Participate in cross-functional meetings to provide regulatory guidance and support decision-making.
14. Collaborate with other departments to ensure timely and successful product launches.
15. Represent the company in external meetings and conferences related to regulatory affairs.

According to JobzMall, the average salary range for a Principal Regulatory Affairs Specialist in Plymouth, MN, USA is $106,000 - $144,000 per year. This range can vary depending on factors such as years of experience, education level, and the specific company and industry.

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.