Principal Regulatory Affairs Specialist

Welcome to the exciting world of regulatory affairs at Philips! As a global leader in health technology, we are dedicated to improving lives through innovative and meaningful solutions. We are seeking a highly qualified Principal Regulatory Affairs Specialist to join our team and drive our products through the complex landscape of regulations and compliance. In this role, you will have the opportunity to work with cutting-edge medical devices and collaborate with cross-functional teams to ensure our products meet the highest regulatory standards. Are you ready to make a difference in the healthcare industry and contribute to the success of Philips? If you have a passion for regulatory affairs, strong leadership skills, and a keen eye for detail, we want to hear from you!

1. Develop and implement regulatory strategies to ensure compliance with global regulations and standards for medical devices.
2. Serve as the primary point of contact for regulatory agencies and ensure timely and accurate communication and submissions.
3. Conduct thorough research and analysis of regulations and standards to provide guidance and recommendations to cross-functional teams.
4. Lead regulatory submissions and ensure all necessary documentation is prepared and submitted in a timely manner.
5. Collaborate with cross-functional teams including R&D, Quality, and Marketing to ensure regulatory requirements are incorporated into product design and development.
6. Manage and maintain product registrations and licenses to ensure compliance throughout the product lifecycle.
7. Keep up-to-date with changes in regulations and communicate any potential impact to the organization.
8. Provide training and guidance to team members and stakeholders on regulatory requirements and processes.
9. Participate in regulatory audits and inspections and provide support for post-market surveillance activities.
10. Act as a subject matter expert and provide guidance to internal and external stakeholders on regulatory matters.
11. Stay current on industry trends and best practices in regulatory affairs to continuously improve processes and procedures.
12. Represent the company in industry meetings and conferences related to regulatory affairs.
13. Monitor and track regulatory changes and assess potential impact on product development and commercialization.
14. Maintain accurate and up-to-date regulatory documentation and records.
15. Support product recalls and field actions as needed.
16. Ensure compliance with company policies and procedures related to regulatory affairs.
17. Provide leadership and mentorship to junior regulatory affairs team members.
18. Identify areas for process improvement and implement changes to increase efficiency and effectiveness of regulatory operations.

According to JobzMall, the average salary range for a Principal Regulatory Affairs Specialist in Colorado Springs, CO, USA is $120,000 - $140,000 per year. However, this can vary depending on factors such as experience, education, and specific job responsibilities. It is important to research and compare job offers to get a more accurate understanding of the salary range for this role in Colorado Springs.

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.