Regulatory Affairs Manager - Core Cardiac Rhythm Management Sustaining

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 this role:

At Boston Scientific, our products and technologies are used to diagnose or treat a wide range of medical conditions. In Cardiac Rhythm Management (CRM), we design, develop, and produce technologies that monitor, support diagnosis, and treat irregular heart rhythms, heart failure and sudden cardiac arrest. We have a robust product portfolio and future pipeline, and we will continue to make an investment in new and improved interventional treatments. We innovate in key areas and are extending our innovations into new geographies and high-growth adjacency markets. Here, you’ll discover a place where you can have meaningful purpose and improve patient’s lives through your daily work.

The Regulatory Affairs Manager role is focused on providing valued regulatory management support for activities within the Core CRM Sustaining Program.  This role will represent the Regulatory Affairs function during cross-functional project meetings and fulfill a people management role with multiple Regulatory Affairs submission specialists as direct reports. Leadership of the team includes cross-functional coordination and influence to strategically align on Franchise goals and strategies, employee development, managing team resources to support franchise priorities, and supporting day-to-day regulatory activities and responsibilities.

This role may work onsite (4+ days/week) or hybrid (3 days/week) at the Arden Hills, MN site.

Your responsibilities will include:

• Oversite management of Core CRM Regulatory Affairs Sustaining Program activities
• Manage a multi-person submission team within a matrixed organization
• Be responsible for required device and accessory product change submission activities - FDA and EU MDR, EU Cert Renewals, US Annual Reports, e-Labeling, International submission support, along with required product release approvals (PRA)
• Assist in establishing project priorities, allocating resources, and managing workloads to achieve business goals
• Study and understand applicability of relevant guidance and regulations and support regulatory-related education efforts and mentoring in areas of expertise
• Provide leadership, regulatory expertise, and training to team members with daily activities, including product change assessments and regulatory submission activities
• Develop and utilize relationships, tools, processes, and other resources to assist in solving problems and gain efficiencies through Sustaining Program Portfolio initiatives
• Establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for the area they support

Required Qualifications:

• Minimum of a Bachelor’s degree
• Minimum of 5 years’ experience working under a medical device quality system or a related discipline (e.g., Regulatory Affairs, Project Management, Quality Systems, R&D, Post Market, Operation Management)
• Working knowledge of FDA, EU and/or international medical device regulations or experience in similar regulated industry/environments
• Demonstrated success in the management or execution of regulatory submission activities, including IDE, PMA, and EU MDR CE marking
• Excellent research and analytical skills

Preferred Qualifications:

• Prior experience leading and/or managing others
• Proven leadership, collaboration and influencing skills
• Excellent written and oral communication
• Ability to manage multiple projects simultaneously
• Track record of working independently with minimal supervision
• Experience with working within R&D project core team as a function lead
• Experience with audits from government bodies (e.g., FDA, MDSAP, ISO 13485), or related activities
• General understanding of product development process, design controls and quality system regulations
• Experience working with Cardiac Rhythm Management products

#LI-Hybrid

Requisition ID: 597567

Minimum Salary: $99,100

Maximum Salary: $188,300

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.