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Sr Regulatory Affairs Specialist


Lawrence, Massachusetts

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Job ID R0054213

PURPOSE AND SCOPE:

The incumbent will manage the regulatory process, both domestic and international markets, for all NxStage Medical, Inc. products and provide regulatory input into key quality system processes, e.g. Design Reviews, Engineering Change Orders, Customer Complaints, etc.

PRINCIPAL DUTIES AND RESPONSIBILITIES

  • Develop regulatory strategies for all NxStage Medical, Inc. products.
  • Prepare and submit US regulatory submissions including 510(k)s, IDEs, pre-submissions, etc.
  • Prepare and submit international regulatory submissions. This includes but not limited to Canada, Europe (CE Mark), Asia, etc.
  • Communicate directly with regulatory agencies on all regulatory issues.
  • Prepare documentation to support “No Filing” decisions for US & international markets.
  • Participate on cross-functional developmental teams including project planning and design review activities.
  • Review and approve Engineering Change Orders in accordance with regulatory requirements.
  • Determine impact and provide regulatory advice on product and system changes.
  • Participate in compliance related activities, including quality system audits, labeling reviews, and verification/validation reviews.
  • Review advertising and promotional documents for compliance with applicable regulations.
  • Maintain corporate regulatory files including technical files/documentation (MDD & MDR).
  • Prepare and maintain FDA Device Listing, Establishment Registration and Baseline Reports.
  • Interface with FDA personnel and Competent Authorities.
  • Perform other related duties as assigned.

PHYSICAL DEMANDS AND WORKING CONDITIONS:

  • The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Travel requirements – Occasional Meetings

EDUCATION:

  • Bachelor’s Degree required

EXPERIENCE AND REQUIRED SKILLS:

  • B.S. in technical discipline preferred
  • 5+ years experience in Regulatory Affairs in the medical device industry including both domestic and international.
  • Experience in process and product development of medical devices.
  • Experience working within the European Union Medical Device Regulations.
  • Experience interacting with FDA/Notified Bodies regarding regulatory matters.
  • Expertise in working within FDA Medical Device Regulations including Quality System Regulation 21 CFR Part 820.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.

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