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Senior Regulatory Affairs Specialist

2 months ago

Arden Hills, United States Boston Scientific Full time

Recruiter: Spencer Gregory Hale

Senior Regulatory Affairs Specialist - Rhythm Management

About this role:

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.

Under minimal supervision, the Senior Regulatory Affairs Specialist is responsible for planning, managing, and implementing regulatory submissions to the US FDA, EU notified bodies, as well as supporting world-wide product registrations. The position is also responsible for ensuring continued compliance with regulatory agency approvals including change impact reviews.

Your responsibilities will include:

  • Supports the development of domestic and international strategies for regulatory approval of Class I, II and III medical devices
  • Coordinates, compiles, and submits U.S. and EU regulatory filings for new and modified products, including PMAs, PMA Supplements, pre-submissions, IDEs, 510(k)s, PMA & IDE Annual Reports, and CE Mark submissions under MDR
  • Supports requests from BSC International Regulatory related to submissions, registrations, and change assessment
  • Develops and maintains positive relationships with regulatory body reviewers
  • Technical and labeling reviews of supporting documents for inclusion in regulatory filings
  • Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
  • Represents RA on cross functional projects which may include product development, manufacturing process changes, and continuous improvement efforts
  • Review of clinical study protocols and other clinical documentation, and assessment of clinical study related changes to determine regulatory impact
  • Support regulatory audits, as required

What we're looking for in you:

Minimum Qualifications

  • Bachelor's Degree
  • 5+ years regulatory affairs or related experience
  • Demonstrated proficiency with relevant US/EU regulatory requirements for medical devices including Quality Systems standards and clinical investigations
  • Demonstrated experience authoring/supporting a variety of regulatory submissions for US and EU, such as original PMAs, PMA Supplements, pre-submissions, IDEs, 510(k)s and CE Design Dossiers, Tech Files, and MDR Tech Docs.
  • Demonstrated ability to effectively manage multiple regulatory projects and priorities
  • Strong technical, research and problem-solving skills
  • Ability to articulate complex ideas clearly both verbally and in writing
  • Demonstrated ability to effectively manage multiple projects and priorities
  • Works well in fast-paced cross-functional team environments
  • Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat

Preferred Qualifications

  • Bachelor's Degree inlife sciences, engineering, or related field
  • Previous experience with Class II or III medical devices submissions is desired
  • Experience working directly with FDA, notified bodies and/or international health authorities is desired

Requisition ID:585935

Among other requirements, Boston Scientific maintains specificprohibited substancetest requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.


Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran