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Regulatory Affairs Specialist

Allentown, PA

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Our client is seeking a Regulatory Affairs Specialist near Philadelphia, PA!

Our client is a medical device company that offers end-to-end solutions through the diagnostic testing kits as well as sample collection/stabilization devices they develop, manufacture, and distribute. Their’ portfolio of products are designed to discover/detect critical medical conditions and are sold on a global scale. They have many years in the industry and have seen continued success throughout their tenure as a business.

Specific Responsibilities:

  • Review and approve labeling changes for compliance with applicable regulations; analyzes and recommends appropriate changes. Including both original labeling and proof review
  • Review validation protocols and change control documentation for compliance with applicable regulations; analyzes and recommends appropriate changes
  • Assist in the preparation of documents based on country-specific requests for legalization. Obtain legalization of documents as required
  • Update Technical Files or other regulatory files as needed
  • Assist in the completion of Annual review of products as required by ISO 13485
  • Assist in the assembly of dossiers and regulatory submissions (PMA, PMA Supplement, IDE, Annual Reports, Design Dossiers, etc.)
  • Maintain departmental archives and records for submissions
  • Support adherence to departmental budgets and initiatives
  • Maintain/create department logs
  • Routinely research, retrieve, analyze, and disseminate guidelines and other regulatory information from the internet, FDA, MDD, IVDD, CMDR, and other appropriate ROW sources
  • Maintain schedule of compliance activities and support (annual product review, risk management files, technical file updates, etc.)
  • Will also be assigned to support the design and implementation of continuous improvement programs in the administration and management of regulatory submissions, clinical trials, and regulatory compliance

Qualifications:

  • Bachelor’s degree in Life Sciences, Physical Sciences, or Engineering with a minimum of 5 years of experience in an FDA regulated industry
  • Dynamic self-motivated individual with strong organizational skills and attention to detail
  • Ability to coordinate and work with multi-functional teams
  • Ability to work with minimal supervision
  • Documented computer skills, particular focus on word processing and presentation formats
  • Strong interpersonal, written, and oral communication skills
  • Ability to use Word, Excel, and other computer software including internet use
  • Capable of multi-tasking and handling tasks with competing priorities effectively