Regulatory Affairs Specialist

Location: San Diego, California, United States
Salary: competitive
Job Type: Contract
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Responsibilities:

Will perform some or all of the following:

  • Help Regulatory Affairs (RA) Lead to obtain and compile documents and information to support In Vitro Diagnostics Regulation (IVDR) requirements within the Technical Documentation Files (TDF's)
  • Work on problems of diverse scope and provide schedules/plans for programs
  • Communicate with internal department functions to obtain required information to support the TDF's
  • Manage activities related to IVDR projects / products
  • Establish and maintain direction of the clinical development through strategic planning with limited direction from supervisor
  • Prepare document packages for 510(k) premarket notifications, Health Canada licenses and EU Technical Files
  • Work closely with marketing to assemble information required to support other international registrations including requests for Food and Drug administration (FDA) Certificates to Foreign Government and Declarations of Conformity
  • Maintain well organized regulatory files for assigned product line by monitoring and tracking information, assuring accurate recordkeeping and preparing documents
  • Assess product and process changes for cleared 510(k) products and assist in determining if changes require updates or new product registrations
  • Perform routine reviews of IVD product labeling, including promotional materials, as assigned; identify label changes that require higher level regulatory review
  • Prepare and maintain regulatory department files for establishment registrations and listings, product registrations, Medical Device Reports (MDR's) and product recalls
  • Compile, organize, and transcribe documentation for regulatory submissions, license renewals, and annual registration
  • Research regulatory information and data to support new product strategies
  • Create and maintain regulatory files and archives, as assigned
  • Stay abreast of regulatory procedures and changes
  • Demonstrate commitment to the development, implementation and effectiveness of Sekisui Diagnostics' Quality Management System per ISO, FDA, and other regulatory agencies
  • Understand and is aware of the quality consequences which may occur from the improper performance of their specific job
  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices
  • Carry out duties in compliance with established business policies
  • Additional duties, as assigned

Organizational Impact / Education / Experience:

  • Bachelor's Degree in Science (Biology, Biochemistry, Chemistry, Medical Technology preferred) or related discipline.
  • Relevant industry experience in IVD devices, Medical Devices, or Pharmaceuticals.

Skills / Pre-requisites:

  • Experience with FDA regulations (21 CFR 820) required
  • ISO 13485, Health Canada Medical Device regulations, EU IVD Directive experience a plus
  • Must be organized and detail oriented
  • Experience participating on multi-functional teams
  • Outstanding oral and written communication skills required

Training:

  • No specific training experience required.

Sthree US is acting as an Employment Business in relation to this vacancy.

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