Regulatory Affairs Specialist

Welcome to Boston Scientific, a leading medical technology company committed to transforming lives through innovative solutions. We are currently seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will play a crucial role in ensuring compliance with regulatory requirements for our products. If you are passionate about making a difference in the healthcare industry and have a strong understanding of regulatory affairs, we encourage you to apply. Join us and be a part of advancing patient care and improving the lives of millions.

1. Ensure compliance with all regulatory requirements for our products.
2. Stay updated on changes in regulatory laws and guidelines and communicate them to relevant departments.
3. Develop and maintain relationships with regulatory agencies and act as a liaison for the company.
4. Review and approve product labeling, marketing materials, and other product documentation to ensure compliance.
5. Prepare and submit regulatory submissions, including 510(k) and PMA applications, and maintain all necessary documentation.
6. Conduct research and provide guidance on regulatory requirements for new product development.
7. Assist in the development of regulatory strategies for new and existing products.
8. Collaborate with cross-functional teams to ensure timely and successful completion of regulatory projects.
9. Participate in audits and inspections by regulatory agencies and ensure all findings are addressed and resolved.
10. Maintain all necessary records and documentation to support regulatory compliance.
11. Provide training and support to internal teams on regulatory requirements and processes.
12. Monitor and track regulatory changes and communicate potential impact to relevant departments.
13. Continuously evaluate and improve regulatory processes and procedures.
14. Represent the company in external meetings and conferences related to regulatory affairs.
15. Adhere to all company policies, procedures, and ethical standards.

According to JobzMall, the average salary range for a Regulatory Affairs Specialist in Maple Grove, MN, USA is between $70,000 and $90,000 per year. This may vary depending on the specific company, level of experience, and other factors such as education and certifications.

Boston Scientific Corp. engages in the development, manufacture and marketing of medical devices that are used in interventional medical specialties. Its products and technologies are used to diagnose or treat medical conditions, including heart, digestive, pulmonary, vascular, urological, women's health and chronic pain conditions.