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Regulatory Affairs and Quality Specialist

The successful candidate will be responsible for a mixture regulatory affairs and quality management system

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Expectations Include:
  • Author, review, and track submissions and other regulatory documents to obtain approval to bring new or modified products to market.
  • Interact and communicate with regulatory health authorities through oral and written communications regarding pre-submissions strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review.
  • Interface and coordinate with FDA and other regulatory agencies on submissions, approvals or other issues.
  • Support marketing, new product development and operations in regulatory assessment of proposed changes. Perform and document regulatory assessments for modifications to existing devices.
  • Interpret existing and/or new regulatory requirements as they relate to company products and procedures. Communicate this to appropriate personnel.
  • Prepare and update US product listings and establishment registration.
  • Prepare and maintain international product registrations.
  • Monitor activities/publications of FDA and international regulatory bodies to identify and respond to new or revised regulatory requirements.
  • Represent Regulatory Affairs during FDA inspections or other government agency audits as required. 
  • Improve the regulatory aspects of the Quality System, developing processes and documenting procedures to maintain an effective quality system.
  • Background in statistics, quality inspection methods, and inspection methods
  • Analyze QMS metrics and develop recommendations for improvement to the Management Team.
  • Completes other tasks as assigned by supervisor.


Requirements:

  • Bachelor’s Degree in a technical or scientific field
  • Minimum 3 years of experience in medical device regulatory affairs
  • Ability to interpret regulatory requirements and communicate them to technical functions within the company
  • Must have experience with successful preparation and submission of Technical File, Design Dossiers, 510(k), and international documents or registration of medical device worldwide. 
  • Knowledgeable of MDD and MDR, ISO13485, IDE and 510(k) premarket notification. 
  • Working knowledge of medical device regulations (21CFR), FDA law and CE marking 
    Experience in supporting international registrations. 

 

ABOUT NEOTERYX

Founded in 2014, Neoteryx is a medical device company shaping the future of healthcare. Our breakthrough blood collection technology – VAMS™ – is used by pharmaceutical giants, organ transplant patients, researchers in economically disadvantaged regions, and others on the leading edge of science and medicine. When you join our fun, tight-knit team, you’ll discover what one drop of blood can do, and be part of microsampling innovations that will change the world.

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