Senior Regulatory Affairs Specialist - Cardiac Rhythm Management

Senior Regulatory Affairs Specialist

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.

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.

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.

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.

Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or…