Regulatory Affairs Specialist II

Regulatory Affairs Specialist II

At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions. About the role : At Boston Scientific, our products and technologies are used to diagnose or treat a wide range of medical conditions. We continue to innovate in key areas and are extending our innovations into new geographies and high-growth adjacency markets. In Interventional Cardiology (IC), we design, develop, and produce technologies for diagnosing and treating coronary artery disease and other cardiovascular disorders. We have a robust product line and pipeline, and we will continue to invest in Interventional treatments. This Regulatory Affairs Specialist II role will provide regulatory support across a broad portfolio of Interventional Cardiology devices, with a primary focus on U.S. and EU compliance activities. Responsibilities include support for U.S. Annual Reports, EU MDR PSUR and SSCP annual reviews, EU MDR recertification activities, audit support, and general compliance initiatives. The role may also include support for new product introductions, evaluation of post-market design changes, and process optimization efforts-aligned with global medical device regulations and broader business objectives. This is a hybrid position based in Maple Grove, MN (in office at least three days per week). Work model, sponsorship, relocation : At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

Your responsibilities will include :

• Represent Regulatory Affairs on core teams, providing regulatory feedback and guidance throughout the project or product development cycle
• Act as a company representative, developing and maintaining positive relationships with regulators through oral and written communications regarding pre-submission strategies, regulatory pathway development, and full submission review processes
• Prepare and submit regulatory documentation and applications focused on compliance requirements
• Review and approve product and manufacturing changes, device labeling, and advertising materials for regulatory compliance
• Support and maintain quality initiatives in accordance with Boston Scientific's Quality Policy
• Participate in the development and implementation of departmental policies and procedures
• Continuously assess ways to improve quality and compliance practices
• Provide internal and external audit preparation and support
• Support innovation within Regulatory Affairs by proposing process optimization and efficiency strategies

Qualifications : Required qualifications :

Preferred qualifications :

Refer to ID 85509617 when applying