Regulatory Compliance Specialist

3 days ago


North Tonawanda, New York, United States Affinity Personnel Solutions Full time
About the Job

We have an exciting opportunity for a Regulatory Compliance Specialist to join our team at Affinity Personnel Solutions in North Tonawanda, NY.

Job Summary:

  • Review design changes to ensure documentation includes necessary justifications, validation and verification updates, risk assessment, etc.
  • Review all applicable design documentation (verification & validation protocols/reports, DRTM, FMEAs, design outputs, etc.).

Responsibilities:

  • Define and maintain training of personnel on all aspects of the Quality System and regulatory standards.
  • Responsible for document change requests, CAPAs, NCRs, temporary deviations, Equipment management.

Requirements:

  • 5+ years of Quality Engineering experience, preferably with technical knowledge and experience in Quality Assurance and/or regulatory functions in the medical device industry.
  • Bachelor's Degree in Mechanical or Biomedical Engineering or related engineering or scientific disciplines.
  • ISO 9001, ISO 13485 and cGMP/21 CFR 820 experience required.
  • Strong self-starter, effective team player.
  • Effective oral, written and presentation skills.
  • Knowledge of Microsoft Office Suite (Word, Excel, PowerPoint, Teams).

Compensation: The estimated salary range for this role is $80,000 - $95,000 per year, depending on experience.



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