Regulatory Affairs Specialist III

 

Additional Location(s): US-MN-Arden Hills

 

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.       

 

About the role:
This position plays a critical role in advancing Boston Scientific’s groundbreaking Atrial Fibrillation technology—the FARAPULSE Pulsed Field Ablation (PFA) System. The FARAPULSE PFA System was the first PFA technology to receive CE Mark approval in Europe and represents a transformative innovation with the potential to shape the future of ablation therapy worldwide.

 

As a Regulatory Affairs Specialist III, you will plan, manage, and implement regulatory submissions to the US FDA, EU notified bodies, and support worldwide product registrations. You will also ensure ongoing compliance with regulatory agency approvals, including leading change impact reviews, while partnering with cross-functional teams to bring innovative therapies to patients around the globe.

 

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. 

 

Your responsibilities will include:

• Support the development of domestic and international strategies for regulatory approval of Class I, II, and III medical devices.

• Represent Regulatory Affairs on cross-functional projects, including product development, manufacturing process changes, and continuous improvement efforts.

• Review and approve design and manufacturing changes for existing products, ensuring compliance with applicable regulations.

• Coordinate, compile, and submit US and EU regulatory filings for new and modified products, including PMAs, PMA Supplements, pre-submissions, 510(k)s, Annual Reports, and CE Mark submissions under MDR.

• Support international regions to gain and maintain product approvals.

• Contribute to continuous improvement of departmental and divisional quality through collaboration, best practices, and knowledge sharing.

• Support regulatory audits, as required.

 

Qualifications:

Required qualifications:

• Bachelor’s degree.

• Minimum of 3 years' experience in Regulatory Affairs or a related discipline within medical devices (R&D, Quality, Clinical, Biocompatibility, Labeling).

• Demonstrated experience authoring and supporting a variety of regulatory submissions for US and EU, such as PMA Supplements, pre-submissions, 510(k)s, Annual Reports, and CE Mark submissions under MDR.

• Proficiency with submission and presentation-related computer skills, including Microsoft Word, Excel, PowerPoint, and Adobe Acrobat.

 

Preferred qualifications:

• Previous experience in the medical device industry with Class II or III device submissions.

• General understanding of the product development process and design controls.

• Working knowledge of FDA, EU, and international regulations.

• Ability to thrive in fast-paced, cross-functional team environments.

• Strong project management skills, with the ability to manage multiple priorities.

• Effective research and analytical skills.

• Strong written and oral communication, technical writing, and editing skills.

• Experience with Boston Scientific capital equipment and/or single-use sterilized devices.

 

 

 

Requisition ID: 615058

Minimum Salary: $76000 

Maximum Salary: $144400 

 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the