Boston Scientific · 1 month ago
Senior Regulatory Affairs Specialist
Arden Hills, MN
Full-time
Hybrid
Mid, Senior Level
$83K/yr - $157K/yr
4+ years expBoston Scientific is a leader in medical science committed to solving significant health industry challenges. The Senior Regulatory Affairs Specialist will manage and implement regulatory submissions to ensure compliance and support product development and market access efforts.
Health CareMedicalMedical Device
No H1B
Responsibilities
Coordinate, compile, and submit U.S. and international regulatory filings for new and modified products, including PMAs, 510(k)s, IDEs, CE Marking submissions, and other country-specific product registrations
Develop and execute domestic and international regulatory strategies for product approvals
Maintain positive relationships with regulatory reviewers through proactive verbal and written communications
Assess product and process changes for regulatory impact and ensure compliance with applicable regulations
Represent Regulatory Affairs on cross-functional product development and clinical project teams, providing regulatory guidance throughout the product lifecycle
Review and approve technical documentation and labeling for inclusion in regulatory submissions
Participate in cross-functional initiatives, including process improvements and change management projects
Qualification
Required
Minimum of a Bachelor's degree or equivalent work experience
Minimum of 4 years' experience in regulatory affairs or related disciplines within the medical device industry (e.g., R&D, Quality, Clinical, Medical Affairs, Post-Market Surveillance)
Demonstrated proficiency with U.S. and international regulatory requirements for medical devices, including Quality Systems standards and clinical investigations
Proficiency with Microsoft Word, Excel, PowerPoint, and Adobe Acrobat
Preferred
Bachelor's degree in life sciences, engineering, computer science, or a related field
Previous experience with Class II or III medical devices
Prior experience interacting directly with the FDA, notified bodies, or international regulatory authorities
Regulatory experience with software as a medical device (SaMD)
Strong written and verbal communication skills with the ability to convey complex ideas clearly
Solid technical, research, and problem-solving abilities
Proven ability to manage multiple projects and priorities effectively
Strong interpersonal skills and a collaborative mindset
Benefits
Compensation 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 may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
Company
Boston Scientific
Boston Scientific is a medical technology company that designs and develops medical devices to diagnose and treat a wide range of condition.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$10.02B2025-02-21Post Ipo Debt· $1.58B
2024-02-22Post Ipo Debt· $2.17B
2022-03-04Post Ipo Debt· $3.28B
Leadership Team
Michael Mahoney
Chairman, President & CEO
Daniel J. Brennan
Chief Financial Officer
Recent News
2026-01-24
2026-01-23
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