Regulatory Affairs Manager - Medical Devices/IVD

Are you passionate about ensuring the safety and efficacy of medical devices and in vitro diagnostics (IVD)? Do you have a strong background in regulatory affairs and a thorough understanding of the industry's ever-evolving regulations? If so, Thermo Fisher Scientific is seeking a highly motivated and experienced Regulatory Affairs Manager to join our team. As a global leader in the healthcare industry, Thermo Fisher Scientific is dedicated to providing innovative solutions that improve patient outcomes. We are looking for a driven individual with a personal commitment to upholding regulatory standards to help us achieve our mission. If you are ready to make a meaningful impact and take on a challenging and rewarding role, then we encourage you to apply for this position.

1. Develop and maintain a thorough understanding of current and evolving regulations for medical devices and IVDs in relevant markets.
2. Ensure compliance with all applicable laws and regulations, including but not limited to FDA, ISO, and other global regulatory requirements.
3. Conduct comprehensive reviews of product labeling, marketing materials, and technical documentation to ensure alignment with regulatory requirements.
4. Collaborate with cross-functional teams to develop and execute regulatory strategies for new product development and product modifications.
5. Prepare and submit regulatory submissions, including 510(k)s, Technical Files, and Design Dossiers, in a timely and accurate manner.
6. Monitor and track changes in regulations and communicate any potential impact to the business.
7. Act as the main point of contact for regulatory agencies, and respond to any inquiries or requests for information.
8. Lead and participate in internal and external audits to ensure compliance with regulatory requirements.
9. Provide regulatory guidance and support to other departments, including R&D, Quality, and Marketing.
10. Proactively identify potential regulatory risks and develop mitigation strategies.
11. Maintain accurate and up-to-date regulatory files and documentation.
12. Stay informed on industry trends and best practices in regulatory affairs.
13. Mentor and train junior team members on regulatory requirements and processes.
14. Represent the company in industry meetings and conferences relating to regulatory affairs.
15. Continuously improve and streamline regulatory processes to increase efficiency and effectiveness.

According to JobzMall, the average salary range for a Regulatory Affairs Manager - Medical Devices/IVD in North Carolina, USA is $100,000 - $140,000 per year. However, this can vary depending on factors such as experience, specific company, and location within North Carolina.

Thermo Fisher Scientific is a U.S.-based provisioner of scientific instrumentation, reagents and consumables, and software and services to healthcare, life science, and other laboratories in academia, government, and industry.