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Principal Project Specialist, Global Reg Affairs Operations Job

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Date: Aug 16, 2019

Location: Maple Grove, MN, US, 55311

Company: Boston Scientific

Additional Locations: Ireland-Galway; US-MA-Marlborough; US-MN-Arden Hills; US-MN-Maple Grove

 

 

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.

 

Purpose:

Global RA Ops is a centralized resource that delivers innovative, agile and sustainable regulatory solutions to empower internal customers throughout the product life cycle. This Notified Body Coordinator position will contribute to the Global RA efficiency projects by centralizing non-standard regulatory responsibilities currently held at the division level and also to align notified body practices across notified bodies and divisions. Centralization of these activities will provide for increased consistency and visibility to issues that may impact global quality system or product approvals.

 

 

Responsibilities:

  1. Act as a single Regulatory Affairs point of contact for the Corporate Notified Bodies and Division regarding EU product approvals and certification management:
    • Represent BSC to Notified Bodies in a consistent and professional manner
    • Host and Plan Meetings
      • Yearly Account Meeting
      • Monthly Meetings on Regulatory Deliverables and Strategy
    • Manage Data
      • Perform Trending and Metrics related to File Review and Audits
      • Maintain Submission Tracker
      • Create and Maintain Product Lists
      • Maintain Sampling Plan
    • Manage Certifications (CE and Quality)
    • Maintain Procedures and Process Flows
  2. MDSAP Audit Support
  • Participate in backroom support for corporate audits
    • Establish and maintain MDSAP Product Lists
  1. Quality System / Cross Divisional Change Support
    • Coordinate Cross Divisional regulatory strategy for product impacting changes
    • Author and submit high level cross divisional quality system change submissions (ex. Supplier site moves)

 

 

Qualifications:

  • 8+ years Regulatory Affairs, Quality Systems, or Project Management experience
  • Medical device industry experience preferred
  • Bachelor’s degree, preferably in a scientific or technical discipline
  • Ability to read and interpret regulations
  • Excellent written and oral communication, technical writing and editing skills
  • Ability to actively engage / collaborate with external regulatory bodies
  • Ability to actively engage / collaborate with internal customers and partners (divisions, regions, quality and operations)
  • Willingness to travel to divisions, regions, regulatory bodies
  • Strong presentation skills
  • Strong data analysis skills

 

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: 448924

 


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