Job Details

  • Title: Regulatory Affairs Associate
  • Code: RCI-6504/6505
  • Location: Irving Texas (TX) 75038
  • Posted Date: 11/16/2020
  • Duration: 12 Months
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  Job Description

REGULATORY AFFAIRS ASSOCIATE - B

 

The position, under supervision of the manager, will help assist in preparing regulatory submissions to FDA and to international regulatory agencies for In-vitro Diagnostic products.

 

Position duties and responsibilities:

  • Review and prepare the required documentation for submission following submission strategy and monitor applications under review.
  • Help maintain regulatory documentation/technical files to ensure product information is current.
  • Assist in maintaining current FDA and international regulations, guidance and applicable standards and communicate submission and approval requirements.
  • Compile, review and coordinate submission documents for license renewals, product/manufacturing changes to Regulatory Agencies and Affiliates.
  • Assist in maintaining various databases
  • Participate in risk-benefit analysis for regulatory compliance.
  • Assists with audits and inspections, as needed.
  • Performs other related duties and responsibilities, on occasion, as assigned.

Must have the following:

  • Candidate must be able to multitask and organize/prioritize tasks to meet deadlines in timely manner.
  • Must have ability to work independently and in groups and demonstrate initiative, problem-solving and critical-thinking skills.
  • Strong verbal and written communication with ability to effectively communicate with multiple functional areas in the organization is necessary.

Education Requirement

  • Science (biology, chemistry etc.) preferred. (Or Equivalency, special qualifications, certifications, licenses, etc.)

Work experience:

  • At least one to three years of work experience.
  • Understanding of scientific disciplines required.
  • Understanding of FDA regulations governing submission processes, submission content, and specific time requirements for various submissions desired.
  • Good computer skills required.