Regulatory Affairs Specialist II in Los Angeles, CA at Volt

Date Posted: 10/5/2018

Job Snapshot

  • Employee Type:
  • Job Type:
  • Duration:
    48 weeks
  • Date Posted:
  • Job ID:
  • Pay Rate
    $0.0 - $32.0/Hour
  • Contact Name
    Volt Branch
  • Phone

Job Description

Volt Workforce Solutions is looking for a Regulatory Affairs Specialist for the Canoga Park Ca Area

Candidate will draft, assemble, and file original documentation and submission materials for new or existing products to regulatory authorities to assure that all submissions are accurate, of high quality and well supported by literature and regulatory foundations, are presented in a manner to facilitate review, and are in conformance with appropriate statutes, regulations, and guidelines.

Key Responsibilities:

  • Track submissions, initiating internal communications and activities to adequately respond to agency inquiries and requests.
  • Develops the regulatory strategy for project team(s). Applies advanced regulatory expertise to the evaluation and solution of submission problems. Actively reviews and edits documents associated with product development meetings.
  • Independently review changes in products, product specifications, and manufacturing processes to assess regulatory implications of the change.
  • Review and approve assigned product labeling, advertising and promotional materials, to ensure full compliance with all applicable FDA and other relevant regulations and industry guidelines.
  • Responsible for vigilance activities, including filing and monitoring recalls/corrections/FSCA, incidents, and MDR's.
  • Review and interpret scientific literature and summarize effectively in writing.
  • Ensure training and compliance with global quality system regulations.
  • Maintains on-going surveillance and analysis of all pertinent domestic and international in vitro diagnostic and medical device regulations to ensure submission requirements world-wide are current, up-to-date.
  • Prepares documents necessary for new product market clearance, approval, and continuance during product life cycle management that includes, but not limited to, 510Ks, supplements, and technical files for CE marketing

Minimum Requirements/Qualifications

  • Bachelor's degree in Biology, Chemistry, bio-engineering or related scientific area or two years' experience in the device / diagnostic, biologic, and / or pharmaceutical industry, primarily in regulatory affairs.
  • 2 years of IVD Regulatory Affairs experience
  • Well versed/knowledgeable in the aspects of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements
  • Experience in the balance and application of regulatory requirements
  • Direct and positive experience in communicating with Regulatory Authorities and Distributors
  • Regulatory review experience of promotional marketing materials, press releases, labeling, etc.
  • Strong oral and written communication skills, as well as the ability to provide scientific presentations
  • Continuous improvement minded; familiar with balancing the need for Quality and the need for efficiency

Volt is an Equal Opportunity Employer