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Regulatory Affairs Generalist

3 months ago

Edison, United States MTF Biologics Full time

Overview/Risks:

Responsible for creating, maintaining and auditing regulatory files including Design History Files, Device Master Records and packaging and labeling files. Participates on project teams and supports the filing of regulatory submissions and reports. As a member of the Regulatory Affairs Department, interacts with various internal departments with minimal supervision.

M-F, 8:15AM - 4:30PM

Responsibilities:
  1. Review and add appropriate documentation to MTFs Design History Files (DHFs), as well as conduct periodic audits of the files, to ensure compliance with MTF Design Control procedures.
  2. Participate on project teams with responsibility to provide regulatory oversight.
  3. Prepare documentation for international and domestic submissions for review by project teams.
  4. Create reviews and update Device Master Records (DMRs) to ensure compliance with applicable regulations.
  5. Update and maintain MTFs Master Label File and Packaging File in accordance with applicable procedures.
  6. Review Finished Goods Specification and Standard Operating Procedures.
  7. Provide backup to Client Quality by collecting information to aid in the investigation of customer complaints, interacts with sales representatives and hospitals, and assists in the closure of these reports.
  8. Collect and review required paperwork on an as-needed basis for submission to regulatory bodies to ensure compliance with the regulations for conducting product recalls..
  9. Assists on special projects and performs additional duties as assigned.
Qualifications:
  1. Bachelors degree in science or a related field or equivalent experience in an FDA regulated environment
  2. Minimum three years experience a compliance role.
  3. Proficiency in Microsoft Word and Excel.
  4. Strong interpersonal and communications skills