Regulatory Affairs Specialist II
About The Position
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).
Requirements
- Minimum of a bachelor's degree in a scientific, technical, or related discipline
- Minimum of 2 years' experience in Regulatory Affairs or related fields (e.g., Quality, Clinical, R&D) within the medical device industry, including at least 1 year in a Regulatory Affairs role
- Introductory knowledge of FDA and EU regulations for medical devices
- Basic computer skills, including proficiency in Microsoft Word, Excel, Teams, PowerPoint, and Adobe Acrobat
Nice To Haves
- Working knowledge of FDA, EU, and international regulations for medical devices
- Ability to manage multiple projects of moderate scope and complexity simultaneously while meeting deadlines
- Effective research, analytical, and problem-solving skills
- Excellent written and oral communication, technical writing, and editing skills; ability to translate technical information into clearly written regulatory messaging
- Advanced computer skills to support submission preparation and internal/external communication (e.g., MS Word linkages, section formatting, table of contents creation)
- Self-motivated, quick learner who can work independently with minimal supervision
- Comfortable working in fast-paced, cross-functional team environments
Responsibilities
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Merchant Wholesalers, Durable Goods
Number of Employees
5,001-10,000 employees
