Regulatory Affairs Specialist Job at Intellectt INC, Cincinnati, OH

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  • Intellectt INC
  • Cincinnati, OH

Job Description

Role: Regulatory Affairs Specialist

Location: Cincinnati, OH (Onsite)

Key Responsibilities:

  • Assist in reviewing and updating regulatory procedures for medical device products under supervision.
  • Ensure compliant storage and organization of key regulatory documentation to support US, EU, and International impact assessments for changes in design, packaging, manufacturing, and labeling.
  • Redline and edit documentation to reflect the latest compliance requirements.
  • Partner with regulatory and business teams onsite to align with internal systems and processes.
  • Manage and track documentation updates using Microsoft Office, spreadsheets, and data/AI-driven tools.
  • Ensure all updates meet global regulatory requirements and internal quality standards.
  • Collaborate with cross-functional teams to drive timely and accurate documentation.

Qualification:

  • Bachelor's degree in Life Sciences, Engineering, or related field.
  • 2 4 years of experience in regulatory affairs, quality assurance, or documentation (medical device industry highly preferred).
  • Strong understanding of regulatory concepts with the ability to interpret compliance and technical details.
  • Exceptional writing, editing, and reviewing skills with sharp attention to detail.
  • Proficiency in Microsoft Office Suite; experience with data/AI-driven documentation tools is a plus.

Job Tags

Work at office,

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