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Regulatory Specialist

Regulatory Specialist

Bedford, MA • Regulatory Affairs

POSITION SUMMARY/ROLE AND RESPONSIBILITIES:

  • Support in the preparation/submission of robust regulatory applications in accordance with organizational objectives
  • Create, review, and approve engineering change orders
  • Act as a regulatory representative on product development teams, communicate regulatory requirements •
  • Provide guidance and expertise on – risk analysis, quality system requirements, verification/validation testing, biocompatibility etc.
  • Maintain ongoing surveillance and analysis of pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, and up to date
  • Support implementation of Quality Management System
  • Conduct internal/supplier audits

WORKING CONDITIONS: Typical office work related activities.

Requirements: 

QUALIFICATIONS AND EDUCATION REQUIREMENTS

  • BA or BS degree; Scientific or engineering field preferred.
  • 2-4 years of technical experience, including at 1+ years of regulatory experience in a medical device industry
  • Experience with 510(k) applications, PMA supplements and US device regulations and/or experience with EU and other international medical device regulations and submissions
  • Must have knowledge of U.S. and/or European/International regulations and standards
  • Experience in preparing regulatory submissions.

KNOWLEDGE/SKILLS: 

  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
  • Must demonstrate good technical writing skill
  • Must work well in team environments • Proficient on programs under Microsoft office; proficient in formatting submission documents
  • Proven analytical abilities
  • FDA 510k, PMA regulations
  • EU MDR requirements

PREFERRED SKILLS: RAC Certification

Send cover letter and resume to Janet Desaulniers

Additional Info

Job Type : Full-Time

Education Level : ""

Experience Level : ""

Job Function : ""

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