Senior Regulatory Affairs Specialist

• Cardiac Rhythm Management Boston Scientific
• 3.9 Arden Hills, MN Job Details $85,000
• $161,500 a year 7 hours ago Qualifications Microsoft Word Microsoft Excel Medical law Presentation software Documentation tools Biomedical regulatory compliance Quality systems Technical Proficiency Adobe Acrobat Full Job Description 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:

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. At Boston Scientific, you'll discover a place where you can have meaningful purpose

• improving lives through your life's work.

In Cardiac Rhythm Management (CRM), we offer diagnostic and treatment solutions for irregular heart rhythms and heart failure, as well as protection against sudden cardiac arrest. We continue to innovate in key areas, extending our products into new geographies and high-growth adjacent markets. Under minimal supervision, the Senior Regulatory Affairs Specialist will plan, manage and implement regulatory submissions to the U.S. Food and Drug Administration (FDA), European Union notified bodies and other global regulatory agencies. This individual will help ensure continued compliance with regulatory approvals by evaluating the impact of product and process changes. The role plays a critical part in supporting product development, global registrations and market access efforts. 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. Relocation assistance is not available for this position at this time.

Your responsibilities will include:

Coordinate, compile and submit U.S. and international regulatory filings for new and modified products, including premarket approval applications (PMAs), 510(k) submissions, investigational device exemptions (IDEs), CE marking submissions and other country-specific product registrations. Develop and execute domestic and international regulatory strategies to support product approvals. Drive regulatory agency interactions, including FDA Q-Submission meetings, European Union notified body structured dialogue discussions and other international regulatory agency pre-consultations and discussions. Represent the company during negotiations and reviews with the FDA, European Union notified bodies and international regulatory colleagues supporting submissions outside the United States, ensuring alignment on regulatory expectations. 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 life cycle. Review and approve technical documentation and labeling for inclusion in regulatory submissions. Participate in cross-functional initiatives, including process improvement and change management projects.

Qualifications:

Required qualifications: Bachelor's degree or equivalent work experience. Minimum of 4 years' experience in regulatory affairs or related disciplines within the medical device industry, such as research and development, Quality, Clinical, Medical Affairs or Post-Market Surveillance. Demonstrated proficiency with U.S. and international regulatory requirements for medical devices, including quality system standards and clinical investigations. Experience in the medical device industry working with Class II and Class III medical devices. Proficiency with Microsoft Word, Excel and PowerPoint, as well as Adobe Acrobat. Prior experience interacting directly with the FDA, notified bodies or international regulatory authorities.

Preferred qualifications:

Bachelor's degree in life sciences, engineering, computer science or a related field. Previous experience with Class II or Class III cardiovascular implantable electronic medical devices. Regulatory experience supporting programs throughout the software development life cycle. Exceptional critical-thinking, strategic-planning, risk-based decision-making and execution capabilities in a fast-paced, results-oriented organization. Strong written and verbal communication skills, with the ability to convey complex ideas clearly. Strong technical, research and problem-solving abilities. Proven ability to manage multiple projects and priorities effectively. Strong interpersonal skills and a collaborative mindset.

Requisition ID:

633568

Minimum Salary:

$ 85000

Maximum Salary:

$ 161500 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).

For MA positions:

It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability. Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn. Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of

COVID-19

vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the

COVID-19

vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to

COVID-19

vaccination.