Principal Regulatory Affairs Specialist

Boston Scientific • Austin, TX

1d • $97,000 - $184,300 • Hybrid

About The Position

Join our Interventional Cardiology team; our products improve patient outcomes and enhance lives by providing the most advanced and broadest set of therapy solutions. Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day. The Principal Regulatory Affairs Specialist is responsible for planning, managing and implementing regulatory submissions to the U.S. Food and Drug Administration (FDA), EU notified bodies and worldwide product registrations. This role supports both new product development and ongoing compliance for a broad ablation portfolio, collaborating with cross-functional teams and international regulatory partners to ensure alignment and success.

Requirements

• Bachelor’s degree in a relevant scientific or engineering discipline.
• Minimum of 7 years' experience in Regulatory Affairs, or minimum of 5 years' experience with an advanced degree in a related discipline.
• Demonstrated leadership in regulatory strategy, project planning and cross-functional execution.
• Experience interpreting global regulatory requirements to ensure alignment with cost, schedule and performance goals.
• Proven ability to influence and negotiate with global regulatory authorities.
• Proficiency with U.S. and EU medical device regulations, including quality system standards and clinical investigation requirements.
• Strong understanding of the product lifecycle, including development, clinical studies, manufacturing and change control.
• Hands-on experience preparing IDEs, 510(k)s and EU MDR submissions.
• Excellent analytical, technical writing and communication skills.
• Proficiency in Microsoft Word, Excel, PowerPoint and Adobe Acrobat.

Nice To Haves

• Direct experience submitting regulatory filings to the FDA, EU MDR and other global agencies.
• Deep knowledge of FDA regulations, EU MDR, MDCG guidance, ISO 13485, ISO 14971 and related global standards.
• Ability to work independently and mentor junior regulatory staff.
• Experience serving as the primary regulatory contact for the FDA and/or notified bodies.
• Proven ability to manage multiple projects and priorities effectively.
• Strong problem-solving mindset with a focus on quality, results and timely delivery.

Responsibilities

• Collaborate on development of sterilization approaches for cardiovascular devices, ensuring alignment with applicable standards, including ISO 11135, ISO 11137, ISO 11737 and ISO 11607, while supporting validation, submissions and lifecycle changes.
• Lead regulatory assessment of sterilization process changes, ensuring continued compliance with global requirements and integration with biocompatibility and MDR and FDA expectations.
• Represent the Regulatory Affairs function on cross-functional teams for new product development and sustaining activities, including manufacturing changes, site transfers and continuous improvement projects.
• Develop U.S. and EU regulatory strategies and prepare submissions for Class II and III medical devices.
• Create innovative regulatory pathways that support new technologies in collaboration with R&D, Quality, Operations, Medical Safety and Clinical teams.
• Prepare, coordinate and compile regulatory submissions, including IDEs, 510(k)s, EU MDR technical documentation and pre-submissions.
• Partner with international regulatory teams to support outside the United States (OUS) registrations and post-market activities.
• Evaluate product and manufacturing changes for regulatory impact and ensure timely, compliant updates to filings.
• Lead interactions with the U.S. FDA and EU notified bodies to secure regulatory clearance and approval while ensuring alignment throughout the review process.
• Provide timely product and project information to global regulatory teams and communicate international requirements to project stakeholders.
• Foster effective relationships with regulatory agencies by delivering clear, strategic communications and follow-up.
• Apply strong project management and technical writing skills to drive regulatory deliverables across multiple initiatives.

Benefits

• 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 role.
• Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.
• At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.
• Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
• Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

What This Job Offers

• Job Type: Full-time
• Career Level: Principal