Senior Regulatory Affairs Specialist - SEISMIQ

About the role:

Join the SEISMIQ team supporting an innovative intravascular lithotripsy system that combines reusable console technology with coronary and peripheral catheter platforms. The Senior Regulatory Affairs Specialist will provide regulatory support for the SEISMIQ console portfolio, with particular emphasis on capital equipment, embedded software, electrical and optical subsystems, cybersecurity, human factors, and console-to-catheter system interfaces. This role is responsible for developing and executing regulatory strategies, preparing submissions and technical documentation, assessing product and manufacturing changes, and partnering with cross-functional teams to maintain global approvals and continued compliance throughout the product lifecycle.

Work model, sponsorship: At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in a 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:

• Develop and implement U.S., EU, and international regulatory strategies for new and modified console products, features, accessories, and system-level changes, with guidance from management or principal-level regulatory partners for the most complex or precedent-setting matters.

• Prepare, coordinate, author, and maintain regulatory submissions and supporting documentation, which may include 510(k)s, PMA supplements, pre-submissions, annual reports, EU MDR technical documentation, and international registration packages.

• Serve as the Regulatory Affairs representative on cross-functional console development and sustaining teams, providing regulatory feedback throughout design, verification and validation, transfer, manufacturing, and post-market lifecycle activities.

• Assess console product, software, cybersecurity, electrical, optical, mechanical, supplier, manufacturing, and service changes for regulatory impact and document clear, timely filing recommendations.

• Partner with Systems, Software, Electrical, Mechanical, Human Factors, Cybersecurity, Design Assurance, Quality, Clinical, Medical Safety, Operations, Service, and international regulatory teams to ensure submission content is complete, consistent, and technically supported.

• Review console design and technical documentation for regulatory readiness, including device descriptions, architecture and interface information, software documentation, cybersecurity documentation, electrical safety and EMC evidence, usability engineering, risk management, verification and validation reports, labeling, installation, service, and maintenance information.

• Develop and maintain productive working relationships with FDA, EU Notified Body, and other regulatory reviewers through clear written and oral communications; support responses to questions and follow-up requests during active reviews.

• Coordinate with international regulatory partners to communicate console-specific requirements, provide technical documentation, and support new registrations, renewals, and change notifications.

• Support regulatory audits and inspections, quality system integration activities, and continuous improvement initiatives related to the SEISMIQ console portfolio.

• Apply sound project management, prioritization, and technical writing skills to manage multiple regulatory deliverables and meet program timelines.

• Maintain a primary commitment to patient safety and product quality by ensuring compliance with Boston Scientific’s Quality Policy, applicable procedures, and global regulatory requirements.

Qualifications:

Required qualifications:

• Bachelor’s degree in a scientific, engineering, or related technical discipline.

• Minimum of 5 years of experience in Regulatory Affairs or a related medical device discipline, or a minimum of 3 years of experience with an advanced degree in a related discipline.

• Direct regulatory experience with either capital equipment, reusable electromechanical systems, energy-delivery devices, or software-enabled medical devices.

• Working knowledge of U.S. and EU medical device regulations, including FDA submission requirements, EU MDR, quality system requirements, and change assessment principles.

• Hands-on experience preparing or supporting regulatory submissions and technical documentation for Class II and Class III medical devices.

• Experience supporting product development and sustaining activities across the medical device lifecycle, including design controls, risk management, verification and validation, manufacturing, and change control.

• Demonstrated ability to independently manage defined regulatory workstreams, identify issues, recommend solutions, and appropriately escalate complex or high-risk matters.

• Strong analytical, technical writing, organizational, and communication skills.

• Proficiency in Microsoft Word, Excel, PowerPoint, and Adobe Acrobat.

Preferred qualifications:

• Experience with device software documentation, software lifecycle considerations, cybersecurity, electrical safety, electromagnetic compatibility, or human factors/usability requirements for medical electrical equipment.

• Experience supporting 510(k), PMA supplement, pre-submission, EU MDR technical documentation, or international filings for console, generator, controller, or other system-based products.

• Experience evaluating hardware, software, supplier, manufacturing, service, and system-interface changes for regulatory impact.

• Familiarity with medical electrical equipment and software standards such as IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 62366-1, ISO 14971, and related cybersecurity expectations.

• Experience interacting with FDA, EU Notified Bodies, or other global regulatory authorities.