Principal Regulatory Affairs Specialist

At Philips, our mission is to improve people's lives through meaningful innovation. As a Principal Regulatory Affairs Specialist, you will play a crucial role in ensuring that our products comply with all relevant regulations and standards, allowing us to bring them to market and make a positive impact on the world. We are looking for a highly skilled and experienced individual who is passionate about regulatory affairs and has a deep understanding of the medical device industry. If you are a detail-oriented, strategic thinker with excellent communication and leadership skills, we invite you to join our team and help shape the future of healthcare.

1. Develop and maintain a comprehensive understanding of relevant regulations and standards for medical devices.
2. Collaborate with cross-functional teams to ensure products are designed and manufactured in compliance with all applicable regulations.
3. Lead and oversee the preparation of regulatory submissions for product approval and clearance.
4. Stay current with changes in regulations and communicate updates to internal stakeholders.
5. Provide regulatory guidance and support to project teams throughout the product development process.
6. Conduct thorough risk assessments and develop strategies to mitigate any potential regulatory issues.
7. Represent the company in interactions with regulatory agencies and respond to inquiries or requests for information.
8. Ensure all regulatory documentation is accurate, complete, and submitted in a timely manner.
9. Monitor and track regulatory submissions and approvals, identifying and addressing any potential delays or issues.
10. Mentor and train junior regulatory affairs team members and provide guidance on complex regulatory matters.
11. Advise on regulatory implications of new product concepts and updates to existing products.
12. Participate in audits and inspections by regulatory agencies and assist in the resolution of any findings.
13. Continuously evaluate and improve regulatory processes and procedures to ensure compliance and efficiency.
14. Serve as a subject matter expert on regulatory affairs within the company and keep management informed of any potential risks or concerns.
15. Collaborate with other departments, such as R&D, Quality, and Marketing, to ensure regulatory requirements are considered in all aspects of the product lifecycle.

According to JobzMall, the average salary range for a Principal Regulatory Affairs Specialist in Latham, NY 12110, USA is $100,000 - $150,000 per year. This salary range can vary depending on factors such as the candidate's level of experience, education, and the specific company they work for. Additionally, bonuses and benefits may also be included in the total compensation package.

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.