Regulatory Affairs Manager

Welcome to Boston Scientific, a global medical technology company dedicated to transforming lives through innovative medical solutions. We are seeking a highly motivated and experienced Regulatory Affairs Manager to join our team and help us navigate the complex regulatory landscape for our life-changing products. As a Regulatory Affairs Manager, you will play a crucial role in ensuring our products meet all necessary regulatory requirements, allowing us to bring them to market and improve patient outcomes. We are looking for a driven individual with a strong understanding of regulatory affairs and a passion for making a positive impact in the healthcare industry. If you have the skills and qualifications we are looking for, we invite you to apply and join us in our mission to improve the lives of patients worldwide.

1. Develop and implement regulatory strategies for new and existing products to ensure compliance with global regulatory requirements.
2. Serve as the primary point of contact for all regulatory agencies, including the FDA and international regulatory bodies.
3. Monitor and interpret changes in regulations and communicate potential impact to relevant teams within the company.
4. Prepare and submit regulatory filings, including 510(k) submissions, PMAs, and CE mark applications.
5. Collaborate with cross-functional teams to gather necessary information and documentation for regulatory submissions.
6. Conduct internal audits to ensure compliance with regulations and company policies.
7. Maintain all necessary regulatory documentation and ensure it is up-to-date and accurate.
8. Participate in product development meetings to provide regulatory guidance and ensure compliance throughout the development process.
9. Represent the company in regulatory meetings and interactions with regulatory agencies.
10. Provide regulatory support for product labeling, promotional materials, and advertising.
11. Train and educate company personnel on relevant regulatory requirements and updates.
12. Stay informed about industry trends and changes in regulations to proactively identify potential risks or opportunities for the company.
13. Collaborate with external consultants and legal counsel as needed.
14. Ensure timely and accurate completion of all regulatory activities to meet product launch timelines.
15. Uphold a high standard of ethical conduct and maintain strict confidentiality in all aspects of the job.

According to JobzMall, the average salary range for a Regulatory Affairs Manager in Arden Hills, MN, USA is between $97,000 and $114,000 per year. This salary range may vary depending on the specific company, years of experience, and additional qualifications or certifications. Additionally, company benefits and bonuses may also impact the overall salary package.

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.