Principal Regulatory Affairs Specialist

"Are you a seasoned regulatory affairs professional with a passion for medical technology? Do you thrive in a fast-paced and dynamic environment? If so, we have an exciting opportunity for you! Philips is seeking a highly skilled Principal Regulatory Affairs Specialist to join our team and drive regulatory strategies for our innovative healthcare solutions. As a key member of our global regulatory affairs team, you will play a critical role in ensuring compliance with global regulations and standards, while contributing to the development and commercialization of life-saving products. If you have a strong understanding of the medical device industry and a proven track record of successful regulatory submissions, we invite you to apply for this challenging and rewarding position."

1. Develop and implement global regulatory strategies for medical technology products.
2. Ensure compliance with global regulations and standards, including FDA, EU, and other international regulatory agencies.
3. Conduct thorough research and analysis of regulatory requirements for new and existing products.
4. Collaborate with cross-functional teams to develop and execute regulatory plans for product development and commercialization.
5. Prepare and submit regulatory documents, including 510(k)s, PMAs, and other submissions, in a timely and accurate manner.
6. Act as a liaison with regulatory agencies, responding to inquiries and requests for information.
7. Stay up-to-date on changes in regulations and standards, and communicate potential impact to stakeholders.
8. Provide regulatory guidance and support to product development teams, ensuring compliance throughout the product lifecycle.
9. Participate in regulatory audits and inspections, and drive corrective actions as needed.
10. Mentor and train junior regulatory affairs team members.
11. Maintain accurate and organized regulatory documentation and records.
12. Collaborate with quality assurance, clinical, and marketing teams to develop labeling and promotional materials that comply with regulatory requirements.
13. Serve as a subject matter expert on regulatory affairs, providing guidance and support to internal and external stakeholders.
14. Identify and mitigate potential regulatory risks and issues.
15. Participate in industry conferences and events to stay informed on regulatory trends and best practices.

According to JobzMall, the average salary range for a Principal Regulatory Affairs Specialist in San Diego, CA, USA is $110,000-$130,000 per year. This may vary depending on factors such as experience, education level, and the specific company or 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.