Regulatory Affairs Specialist III
About The Position
At Boston Scientific, we advance science for life by transforming deep clinical insights into meaningful innovations that improve patient lives. Our Interventional Cardiology (IC) division focuses on developing and delivering technologies to diagnose and treat coronary artery disease and other cardiovascular disorders. We are continually investing in both our robust product portfolio and our expanding global presence. As a Regulatory Affairs Specialist II, you will support a broad range of Interventional Cardiology devices, with an emphasis on sustaining commercial products and executing regulatory submissions for the US and EU. This role offers the opportunity to make a direct impact on patient care by ensuring product compliance and navigating global regulatory requirements.
Requirements
- A 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
- Strong technical writing and editing abilities
- Ability to translate complex technical content for regulatory audiences
- Proficiency in Microsoft Word, Excel, Teams, PowerPoint, and Adobe Acrobat
- Working knowledge of FDA, EU, and international medical device regulations
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 Renal Denervation devices within the Interventional Cardiology 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 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
