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:
As a Regulatory Affairs Associate Director, you will be responsible for leading a diverse team of Regulatory talent managing a group of Cardiac Rhythm Management (CRM) product lines, technology and specialized functions. This role will serve as a regulatory subject matter expert supporting Boston Scientific’s Conduction System Pacing (CSP), cardiac leads, and leadless pacemaker portfolios. You will lead regulatory strategy across global markets, guide cross-functional teams, and lead the design, build, and implementation of programs and initiatives designed to improve the effectiveness of the CRM Regulatory Affairs team. A significant portion of time will be devoted to managerial, leadership, and employee development responsibilities.

At Boston Scientific, we value collaboration and synergy.  This role follows a hybrid work model, requiring employees to be in our Arden Hills, MN site at least three days per week.

Your responsibilities will include:

Regulatory Strategy & Execution

• Develop and implement global regulatory strategies for new and existing products
• Oversee preparation and submission of global regulatory license applications (e.g., 510(k), PMA, IDE, EU MDR, international registrations)
• Provide regulatory input on product changes, clinical studies, and market expansion
• Provide technical guidance to CRM organization during strategy formulation, submission preparation and interaction with regulatory bodies
• Oversee review of device labeling and advertising materials for compliance with submissions and applicable regulations; analyze and recommend appropriate changes

Leadership

• Act as regulatory lead on cross-functional project teams
• Collaborate with Program Management, R&D, Quality, Clinical, and Operations to ensure regulatory compliance and readiness
• Mentor and guide junior team members; including directing and coordinating activities of Regulatory Affairs employees under direct and indirect supervision
• Provide day-to-day management of Regulatory Affairs function for CRM business
• Establish project priorities, allocating resources and workload
• Review and edit submissions prepared by Regulatory Affairs personnel
• Review and sign off on product and manufacturing change submissions
• Provide Regulatory Affairs training / mentoring to other employees

Agency & Audit Support

• Serve as liaison with global regulatory bodies and internal stakeholders
• Support external audits (e.g., FDA, Notified Bodies) and maintain audit readiness
• Participate in quality system activities and regulatory intelligence efforts

Process Improvement & Collaboration

• Contribute to the development of best practices across the Regulatory Affairs function
• Support due diligence and integration for new business opportunities

Required Qualifications:

• Bachelor’s degree or higher
• Minimum of 10 years of experience in Regulatory Affairs or related fields (e.g., Quality, R&D, Program Management)
• Minimum 3 years of experience managing cross-functional teams, including direct supervision, mentoring, and/or leading projects from initiation through execution and delivery, using structured project management methodologies and tools
• Experience with regulatory submissions (e.g., 510(k), IDE, PMA, MDR CE Marking, international registrations)

Preferred Qualifications:

• Prior experience with implantable cardiac devices / Class II and III medical devices
• Demonstrated ability to effectively work cross-functionally with Program Management, R&D, Clinical, Quality, and/or Operations
• Strong communication, collaboration, and organizational skills
• Experience supporting clinical studies and audits
• Familiarity with international regulatory requirements
• Knowledge of CRM products and technologies

LI-Hybrid

Requisition ID: 608205

Minimum Salary: $133700 

Maximum Salary: $254000 

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.

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. 

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 identify, 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.