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Job Details

Regulatory Documentation Specialist

  2025-05-05     Akkodis     Columbus,OH  
Description:

Akkodis is seeking a Regulatory Documentation Specialist for a Contract job with a client in Columbus, OH(Hybrid) . The ideal candidate is responsible for ensuring compliance with regulatory and quality standards, supporting audits, and maintaining effective documentation systems.

Rate Range: $36/hour to $40/hour; The rate may be negotiable based on experience, education, geographic location, and other factors.

Regulatory Documentation Specialist job responsibilities include:

  • Supporting external audit activities (FDA, FDB, ISO registrar audits, etc.).
  • Auditing areas of the Vascular Quality System for compliance.
  • Generating and distributing periodic open CAPA and Internal Audit Corrective Action (IACA) reports.
  • Tracking and trending compliance activities, including CAPA and IACA metrics.
  • Assisting in obtaining timely feedback on open corrective actions.
  • Participating in cross-divisional activities to integrate quality system information.
  • Reviewing and updating Quality System procedures as necessary.
Desired Qualifications:
  • Bachelor's Degree or equivalent.
  • 4+ years of related work experience or equivalent combination.
  • Strong knowledge of regulatory compliance standards (FDA, ISO, etc.).
  • Experience with quality systems management, including CAPAs and internal audits.
If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis, or any questions, feel free to contact me at nitish.kumar2@ akkodisgroup.com

Pay Details: $36.00 to $40.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
  • The California Fair Chance Act
  • Los Angeles City Fair Chance Ordinance
  • Los Angeles County Fair Chance Ordinance for Employers
  • San Francisco Fair Chance Ordinance


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