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Principle Regulatory Affairs Specialist

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Hybrid
Onsite Location(s): 

Clonmel, TA, IE

Additional Locations: Ireland-Clonmel; Ireland-Cork; Ireland-Galway

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - 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.

 

 

Purpose Statement

The Regulatory Associate is responsible for activities which lead to, and maintain regulatory approval to market devices.  Additionally, the Associate is responsible for assessment of device changes for regulatory implications.

 

Responsibilities  

 

  • Develop strategies for regulatory approval of medical devices.
  • Coordinate submission activities for a variety of device regulatory approvals including: US premarket approvals, international design dossiers, post-approval reports, export certificates, clinical trial exemptions and establishment registrations and listings.
  • Serve as internal consultant on regulatory issues such as recalls, advertising and promotional activies, field actions or review of proposed device changes. (Some activities are CRM only)
  • Develop and deliver presentations to global regulatory agencies.  Topics may include submission strategies, compliance issues or new initiatives such as Global Harmonization.  Coordinate Guidant comments on proposed regulations.
  • Communicate submission and/or advertising and promotion requirements to internal customers such as product development teams.
  • Research regulatory requirements for assigned geographies. Monitor emerging trends and integrate new requirements into department procedures and toolkits.
  • Participate in training and mentoring of staff.
  • Coordinate IFU development activities (VI & ES only).
  • Participate in department systems development initiatives.


 

 

What we’re looking for in you: 

Required Qualifications 


•    Minimum of a Bachelor’s degree or equivalent work experience
•    Minimum of 5 years’ experience in Regulatory Affairs or related discipline in medical devices (R&D, Quality, Clinical, Medical Affairs, Biocompatibility)
•    General understanding of product development process and design controls
•    Working knowledge of FDA, EU and/or international regulations

 

 

Preferred Qualifications 


•    Minimum of a Bachelor’s degree in preferably in a scientific or technical discipline
•    General understanding of regulations applicable to the conduct of clinical trials
•    Ability to manage several projects simultaneously
•    Proficiency with Microsoft Office applications (Word, Excel, PowerPoint)
•    Effective research and analytical skills
•    Effective written and oral communication, technical writing and editing skills
•    Ability to work independently with minimal supervision

 

Requisition ID: 528517

 

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!


Job Segment: Regulatory Affairs, Compliance, Medical Device, Law, Technical Writer, Legal, Healthcare, Technology

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