Apply now »

Principal Regulatory Affairs Specialist

Work mode:  Hybrid
Onsite Location(s): 

Maple Grove, MN, US, 55311

Additional Location(s): US-MN-Maple Grove; Ireland-Cork; Ireland-Galway

 

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 the Principal, Regulatory Affairs within Regulatory Operations, you will play a key role in regulatory oversight and support of Peripheral Intervention (PI) medical device sustaining activities. You will spend time planning, communicating, and leading Regulatory Affairs (RA) initiatives to sustain PI products.  Additionally, you will collaborate across functions or divisions, sharing your technical knowledge of regulatory requirements and influencing stakeholders to drive efficient regulatory processes in support of business growth.

 

This role reports to the Director, Regulatory Affairs and is a hybrid position (in office minimum three days per week) located in either Maple Grove, Minnesota or Cork or Galway, Ireland.

 

Your responsibilities will include: 

  • Conducting Regulatory Operations activities, such as:
    • Oversight of PI Postmarket Surveillance (PMS) within PI RA and serve as point-of-contact for key stakeholder groups (DA, Clinical Risk, etc.). This may include development and implementation of processes for maintenance of EU technical documentation / MDR Sustainment (i.e., SSCPs, GSPRs, etc.)
    • Support certificate activities (new/maintenance), periodic Notified Body meetings, file sampling, recertifications, etc.
    • Help drive cadence for PMS activities, periodic reviews, MDR implementations, End-Of-Life activities, etc.
    • Chair various Regulatory forums for ongoing learning/collaboration
    • Provide regulatory training/mentoring to other RA employees and cross-functional teams
    • Identify regulatory risks/gaps in current processes needed for ongoing compliance
  • Communicating effectively with PI Regulatory Affairs team, leadership, and other stakeholders. 
  • Serving as an advisor and subject matter expert for ongoing EU MDR sustainment activities across PI RA
  • Serving as point-of-contact for ongoing Global RA Ops initiatives needing PI Divisional support
  • Developing relationships and collaborations which may enhance efficiencies, growth, and priorities
  • Executing regulatory submissions as needed to support business needs
  • Sense of urgency, responsiveness, and commitment to execution

 

Required qualifications: 

  • Minimum of a bachelor’s degree 
  • Minimum of 7 years’ experience in Regulatory Affairs or a related discipline (e.g. Quality, R&D, Post Market) within the medical device, IVD,
  • pharmaceutical or healthcare industries
  • Demonstrated proficiency with relevant US/EU regulatory requirements for medical devices including Quality Systems standards 
  • Prior experience with a variety of regulatory submissions for US and EU MDR
  • Previous experience interacting with regulators and leading initiatives across functions, divisions, or sites
  • Ability to travel at times up to 20%

 

Preferred qualifications: 

  • Adaptable and able to work independently with minimal supervision in a fast-changing environment
  • Demonstrated leadership, strategic thinking, project planning, and project management skills
  • Excellent oral/written communicator with ability to articulate ideas, transfer knowledge efficiently and effectively, influence and engage colleagues
  • Experience working in complex matrixed organizational structures with demonstrated capability to collaborate and influence across such an organization
  • Ability to effectively lead multiple regulatory projects and priorities
  • Experience working directly with FDA, Notified Bodies, or other regulatory agencies
  • Experience with data analytics or AI tools to identify and drive operational efficiencies is a plus

 

#LI - Hybrid

#LI - KS

 

 

 

 

 

 

Requisition ID: 606462

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.


Nearest Major Market: Minneapolis

Job Segment: Regulatory Affairs, Medical Device, Pharmaceutical, Compliance, Project Manager, Legal, Healthcare, Science, Technology

Apply now »