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Specialist II, Uro/PH, Regulatory Affairs - Remote Job

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Date: Sep 6, 2021

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

Additional Locations: US-MA-Marlborough



Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.



About the role:

The Urology and Pelvic Health business unit provides proven, leading solutions to treat five common urology diseases, including kidney stones, benign prostatic hyperplasia (BPH), erectile dysfunction (ED), male incontinence and pelvic floor disorders. These conditions account for 50 percent of all urology surgical procedures.  Come join a growing, global division and become a member of a large and experienced regulatory team! https://www.linkedin.com/showcase/bsc-uroph/

Responsible for Regulatory Affairs support of initial MDR submissions and on-going regulatory compliance projects for MDR.


Your responsibilities include:

  • Acts as company representative, developing and maintaining positive relationships with reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification, and follow-up of submissions under review.
  • Responsible for management, maintenance, coordination and updates with EU Notified Bodies related to Uro/PH MDR certificate management, including Class III, IIb implantable and lower classification certificates.
  • Responsible for preparation and submission of EU MDR technical documentation, EU Post Market Surveillance Reporting submissions, SSCP, as well as internal regulatory file documentation.
  • Trains to departmental and divisional policies and procedures.
  • Fosters a work environment of continuous improvement in support of BSC’s Quality Policy, Quality System and the appropriate regulations for their area of responsibility.
  • Supports efforts to improve collaboration, knowledge sharing, and best practices within the department and division.


What we’re looking for:
Basic Qualifications

  • Prior EU MDR experience required.  Thorough understanding of EU medical device regulations 
  • Prior experience working with Notified Bodies on substantial/significant changes, and management of Technical File or Design Dossier reviews preferred 
  • Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline
  • 3+ years of experience in Regulatory Affairs or related discipline (e.g., R&D, Quality, Clinical, Medical Affairs, Biocompatibility) within medical device industry

Preferred Qualifications

  • Effective written and oral communication, technical writing and editing skills
  • Excellent research and analytical skills
  • Ability to manage several regulatory projects
  • Ability to work independently with minimal supervision
  • Proficiency with Microsoft Office applications (Word, Excel, PowerPoint)
  • General understanding of standards applicable to medical devices



About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.


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


Requisition ID: 476482


Nearest Major Market: Boston

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