Regulatory Affairs Associate

3 weeks ago

Conshohocken, United States Extremity Care Full time
Job DescriptionJob DescriptionSalary: $65,000+

Purpose:

The Regulatory Affairs Associate is responsible for assessing and ensuring regulatory compliance of the quality management system.


Duties & Responsibilities:


  • Generate audit agenda, plan, summary report, and perform internal audits
  • Assist with supplier qualification for vendors, customers, consultants, and other services (as appropriate)
  • Initiate and investigate quality events
  • Assist with quality event reportability determination to FDA/AATB
  • Author/revise procedures according to FDA, AATB, and other regulations (as appropriate).
  • Support submissions of FDA/AATB reportable events
  • Assist with state license application submissions and renewals
  • Support development of validation protocols to verify compliance with regulatory requirements.
  • Support new projects and product development
  • Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB, other regulations (as appropriate), and industry standards
  • File and maintain records in accordance with standard operating procedures.
  • Perform other related duties as assigned


Skills & Abilities:


  • Excellent attention to detail and organizational skills
  • Ability to work independently & in a team environment
  • Ability to multi-task
  • Effective verbal and written communication skills
  • Extensive Knowledge of applicable government regulations

 

Education & Experience:

 

  • Bachelor’s degree in a biological science or related field required
  • At least 3 years of quality and/or regulatory experience in an FDA regulated environment for HCT/Ps and/or medical devices (or related field)

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