Regulatory Affairs Specialist II

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Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

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.

Cardiac Rhythm Management (CRM) Division – Arden Hills, MN

As part of Boston Scientific’s Cardiac Rhythm Management (CRM) division, you will contribute to delivering advanced, life‑saving and sustaining technologies to patients worldwide. Our innovative solutions diagnose and treat a range of heart conditions—and we continue to expand into new markets with a focus on impactful, emerging technologies.

In this role, you’ll support global regulatory submissions and compliance efforts, working across Class I, II, and III medical devices as well as drug/device combination products. As a Regulatory Affairs Specialist II
, you’ll be encouraged to stay curious, apply critical thinking, and grow your knowledge across technologies and regulatory systems. You’ll join a high‑impact team delivering transformative cardiac therapies to patients across the globe.

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model
, requiring employees to be in our Arden Hills, MN 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.

• Support development of global regulatory strategies for Class I, II, and III medical devices and drug/device combination products
• Coordinate, compile, and submit U.S. and EU regulatory filings for new and modified products—including PMAs, PMA supplements, pre‑submissions, IDEs, 510(k) s, annual reports, and CE Mark submissions under MDR
• Assist with international regulatory requests related to submissions, registrations, and change assessments
• Review product and manufacturing changes for regulatory compliance and filing impact
• Support regulatory audits as required
• Review promotional materials for regulatory compliance
• Represent Regulatory Affairs on cross‑functional projects involving product development, manufacturing changes, and process improvement initiatives
• Support departmental projects such as procedure stewardship, Value Improvement Projects (VIP), and Regulatory Operations activities
• Collaborate with Clinical Affairs on aspects of clinical trials and clinical report development
• Stay informed on emerging technologies and assess their regulatory and organizational implications

• Bachelor’s degree in life sciences, engineering, or a related discipline
• Minimum of 2 years' experience in Regulatory Affairs or a related field
• Strong technical writing skills

• Working knowledge of regulatory requirements for medical devices and drug/device combination products
• Effective written and oral communication skills
• Proficiency with Microsoft Office and Adobe Acrobat
• Experience working on cross‑functional teams
• Internship, work‑study, or coursework involving U.S., EU, or international medical device regulations and quality systems
• Ability to work both independently and collaboratively, with appreciation for diverse perspectives
• Experience interacting with the FDA, Notified Bodies, or international regulatory authorities
• Demonstrated ability to manage multiple projects and shifting priorities

Requisition

Minimum Salary: $71,500

Maximum Salary: $135,800

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see — will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education…