Senior Regulatory Affairs Specialist

Are you a highly skilled and experienced regulatory affairs professional looking for the next step in your career? Look no further! Philips is seeking a Senior Regulatory Affairs Specialist to join our dynamic team. In this role, you will play a critical role in ensuring compliance with global regulations and standards for our innovative medical devices. We are seeking a detail-oriented and proactive individual with a strong understanding of regulatory processes and a passion for delivering high-quality products to the market. If you are ready to take on a challenging and rewarding role with a global leader in healthcare technology, we encourage you to apply.

1. Ensuring compliance with global regulations and standards for the company's medical devices.
2. Keeping up-to-date with changes in regulations and communicating them to relevant stakeholders.
3. Conducting risk assessments and providing recommendations for mitigating potential issues.
4. Collaborating with cross-functional teams to develop and implement regulatory strategies for new products.
5. Preparing and submitting regulatory submissions, such as 510(k) applications and technical files.
6. Reviewing and approving labeling, promotional material, and other product documentation for regulatory compliance.
7. Conducting regulatory assessments for new product development projects and providing guidance on regulatory requirements.
8. Maintaining and organizing regulatory documents and records in accordance with company and regulatory standards.
9. Participating in audits and inspections by regulatory agencies and responding to any findings.
10. Providing training and guidance to team members on regulatory processes and requirements.
11. Proactively identifying and addressing potential regulatory issues and risks.
12. Ensuring timely and accurate completion of all regulatory filings and submissions.
13. Building and maintaining relationships with regulatory authorities.
14. Staying informed about industry trends and changes in regulatory landscapes.
15. Representing the company in meetings and discussions with regulatory agencies.

According to JobzMall, the average salary range for a Senior Regulatory Affairs Specialist in Colorado Springs, CO, USA is $84,000-$116,000 per year. This may vary depending on the specific industry, company, and level of experience of the individual.

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.