Manager, Regulatory Affairs

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.

At Boston Scientific, you'll discover a place where you can have meaningful purpose, improving lives through your life's work. In Rhythm Management (RM) we offer solutions for treating irregular heart rhythms and heart failure and protecting against sudden cardiac arrest. We continue to innovate in key areas and extending our products into new geographies and high-growth adjacency markets.

About this role:

The Regulatory Affairs Manager I supports the Electrophysiology (EP) Franchise goals through leadership of select team members on the Core EP Capital Equipment Regulatory Affairs (RA) team. This leadership role includes cross-functional coordination and influence, employee development, managing team resources to support franchise priorities, and support of day-to-day regulatory activities and responsibilities.

Your responsibilities will include:

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  Direct and coordinate activities of RA employees, including direct supervision and development of RA team supporting EP capital equipment devices

  
  
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  Assist in establishing project priorities, allocating resources, and managing workloads to achieve business milestones

  
  
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  Provide leadership, regulatory expertise, and training to team members with daily activities, including product change assessments and regulatory submission activities

  
  
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  Provide coaching/mentoring to RA team members to meet career/skills development goals

  
  
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  Collaborate cross-functionally to achieve business objectives in the most efficient/effective manner

  
  
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  Represent RA at various internal and external forums, including audits

  
  
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  Assist with developing and implementing departmental policies and procedures

  
  
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  Provide hands on Regulatory support for assigned projects as needed

  
  

Required qualifications:

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  Minimum of a bachelor's degree

  
  
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  Minimum of 5years of direct medical device Regulatory Affairs experience

  
  
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  Experience performing product change assessments, and US/EU regulatory submission activities

  
  

Preferred qualifications:

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  Prior people leadership experience

  
  
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  Experience working with EP products or capital equipment/software devices

  
  

#LI-Hybrid

Requisition ID:602151

Minimum Salary: $99100

Maximum Salary: $188300

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.