Regulatory Auditor - Medical Devices

Posted 13 August by Bosch Global Associates Ltd

Regulatory Auditor - Medical Device - USA

Location: USA, home based.

Travel: Yes.

Salary range: Negotiable.

Type of position: Permanent.

SUMMARY: The Regulatory Auditor position will have a background in regulatory requirements applying to manufacturers’ processes and productsand in auditing manufactures to ensure continued compliance with Quality System Standards. To review all facets of the client’s Quality System including product design, engineering, etc. ensuring compliance to the requirements.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Utilize knowledge of regulatory requirements applying to manufacturing processes and products.

Audit manufacturers to ensure compliance with Quality System Standards (ISO 13485)

Review product design, engineering and manufacturing while documenting any deficiencies

Create audit reports for clients utilizing analytical skills and technical knowledge.

Analyze complex regulatory requirements.

Requirements:

Minimum 4 year degree in either Engineering, Biomedical, Medicine, Pharmacy, (Micro) biology, Biotechnology, Clinical Physics or related discipline of medical devices.

Minimum of 5 years of experience in Medical Device/Regulatory Affairs field.

Broad knowledge of engineering and technical applications.

Experience with internal/external auditing (certified Lead Auditor) to ISO 13485, GMP, MDD, IVD, CMDCAS regulations to include supplier audits, FDA, and notified bodies.

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Required skills

  • Auditing
  • Manufacturing
  • Medical Devices
  • Product Development
  • DESIGN

Application question

Do you have at least 5 years manufacturing OR auditing expertise in medical devices?

Reference: 28553327

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