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:

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

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

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

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

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

• Represent RA at various internal and external forums, including audits

• Assist with developing and implementing departmental policies and procedures

• Provide hands on Regulatory support for assigned projects as needed

Required qualifications:

• Minimum of a bachelor’s degree

• Minimum of 5 years of direct medical device Regulatory Affairs experience

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

 

Preferred qualifications:

• Prior people leadership experience

• 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,