Medical Device Design History File Remediation Specialist

  • location: Exton, PA
  • type: Contract
  • salary: $50 - $80 per hour
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job description

Medical Device Design History File Remediation Specialist

job summary:
In this role, you will evaluate and assess commercial products and/or technologies in compliance with cGMP and ISO standards for any gaps. You will update documents (e.g. design history files, research documentation and studies) per the latest regulatory standards (e.g. 21 CFR 820) and work with a cross-functional team.

location: Exton, Pennsylvania
job type: Contract
salary: $50 - 80 per hour
work hours: 9 to 5
education: Bachelors
  • Transpose historical data and reports into electronic format.
  • Evaluate product DHFs and ensure risk management, and other associated documentation are included and up to date per the latest cGMP standards.
  • Document gaps in DHF and unmet criterions.
  • Carry out DHF remediation activities as per approved remediation plan.
  • Perform risk management and risk analysis activities.
  • Technical writing - reports and technical justification.
  • Develop understanding in functional / system testing of combination products.
  • Review post market surveillance activities as required.
  • Other duties as assigned.
  • Bachelor's degree in medical, chemical, biomedical or related discipline
  • Proficient in Microsoft Office suites (e.g. Word, Excel)
  • Minimum 2 Years of experience in product design/development of combination products
  • Well organized, detail oriented and a self-starter capable of working in a deadline dictated environment
  • Background in medical device or pharmaceutical industry.
  • Experience with product development, design controls, design history files, risk assessments preferred.
  • Experience with technical writing
  • Able to comply with the company's safety policy at all times
skills: GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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