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Regulatory Auditor – Medical Devices

Regulatory Auditor - Medical Gadget - USA

Location: USA, house based mostly.

Journey: Sure.

Wage vary: Negotiable.

Sort of place: Everlasting.

SUMMARY: The Regulatory Auditor place could have a background in regulatory necessities making use of to producers’ processes and productsand in auditing manufactures to make sure continued compliance with High quality System Requirements. To evaluation all sides of the shopper’s High quality System together with product design, engineering, and so on. making certain compliance to the necessities.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Make the most of information of regulatory necessities making use of to manufacturing processes and merchandise.

Audit producers to make sure compliance with High quality System Requirements (ISO 13485)

Evaluate product design, engineering and manufacturing whereas documenting any deficiencies

Create audit reviews for shoppers using analytical expertise and technical information.

Analyze complicated regulatory necessities.

Necessities:

Minimal four yr diploma in both Engineering, Biomedical, Drugs, Pharmacy, (Micro) biology, Biotechnology, Medical Physics or associated self-discipline of medical units.

Minimal of 5 years of expertise in Medical System/Regulatory Affairs subject.

Broad information of engineering and technical purposes.

Expertise with inner/exterior auditing (licensed Lead Auditor) to ISO 13485, GMP, MDD, IVD, CMDCAS laws to incorporate provider audits, FDA, and notified our bodies.

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Required expertise

  • Auditing
  • Manufacturing
  • Medical Devices
  • Product Improvement
  • DESIGN

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Regulatory Auditor – Medical Devices

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