Regulatory Affairs Specialist II
About The Position
At Boston Scientific, we advance science for life by transforming deep clinical insights into meaningful innovations that improve patient lives. Our Peripheral Vascular business unit, within the Interventional Cardiology Therapies (ICTx) division, focuses on developing and delivering technologies to diagnose and treat peripheral vasculature disease. We are continually investing in both our robust product portfolio and our expanding global presence. This Regulatory Affairs Specialist II role will provide regulatory support across a broad portfolio of Peripheral Intervention devices, with a primary focus on U.S. and EU. Responsibilities include evaluation of post-market design changes, support for product and process optimization efforts, EU MDR compliance, and regulatory submissions for all classes of medical devices in the US and EU. This role may also include support for new product introductions and audit support. This role offers the opportunity to make a direct impact on patient care by ensuring product compliance and navigating global regulatory requirements.
Requirements
- Minimum of a Bachelor's degree in Science, Engineering, or a related discipline.
- Minimum of 2 years' experience in Regulatory Affairs or related fields (e.g., Quality, Clinical, R&D) within the medical device industry.
- Proficiency in Microsoft Word, Excel, Teams, PowerPoint, and Adobe Acrobat.
- Working knowledge of FDA, EU, and international medical device regulations.
- Strong technical writing and editing abilities for regulatory documentation.
- Ability to interpret and apply regulatory guidelines and standards.
Nice To Haves
- Excellent written and verbal communication skills.
- Strong interpersonal skills and a collaborative team mindset.
- Self-starter with the ability to work independently and adapt quickly in fast-paced environments.
- Proven ability to manage multiple projects and meet deadlines in a dynamic environment.
- Experience collaborating on cross-functional teams.
Responsibilities
- Supporting Regulatory Affairs activities related to peripheral vascular devices within the ICTx portfolio.
- Representing Regulatory Affairs on core project teams by providing guidance throughout product development and lifecycle management.
- Acting as a liaison with regulatory agencies through written and verbal communications, including submission strategy and pathway development.
- Preparing and submitting regulatory documentation to support global compliance and product approvals.
- Reviewing and approving product changes, labeling, and promotional materials to ensure regulatory compliance.
- Participating in internal initiatives to improve quality systems in alignment with Boston Scientific’s Quality Policy.
- Supporting department and divisional process improvements through collaboration, best practice sharing, and cross-functional engagement.
- Participating in regulatory audits/inspections by agencies such as the FDA, DEKRA, BSI, and HPRA.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
