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Manager of Regulatory Affairs

Company: Cameron Craig Group
Location: Columbus
Posted on: October 12, 2019

Job Description:


Our highly profitable healthcare client is seeking a Manager or Regulatory Affairs to develop and oversee control systems to prevent or deal with violations of legal guidelines and internal policies to be complaint with standard operating procedures, regulatory requirements and commitments in accordance with 21CFR, esp. Parts 800-1299;-- Products Produced by Aseptic Processing Current Good Manufacturing Practice; Relevant ISO documents, EU and JP regulations and relevant USP chapters
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RESPONSIBILITIES:


  • Accountable for the development/implementation of the regulatory strategy for products
  • Conducts assessments including but not limited to regulatory gap analyses, considerations and strategy, risk planning and mitigation
  • Performs audits as required with documentation, labels and external suppliers
  • Lead the development/implementation of innovative strategies for regulatory compliance
  • Monitor changes in the regulatory environment and advise staff accordingly
  • Provide regulatory leadership in early development and due diligence review projects
  • Maintain up-to-date knowledge of regulatory requirements
  • Direct responsibility for compliance, management, and continuous improvement of quality systems
  • Review labeling and promotional activities to ensure they comply with approved claims
  • FDA Drug and Medical Device Registration and listing
  • Annual renewal of permits/licenses (Local, State, Federal)
  • Ensures timely completion and submission of regulatory documents
  • Develop strategies for regulatory approval of medical devices.
  • Responsible for preparation and submission of 510(k)s, IDEs, and Technical Files (CE Mark) to support the multiple product lines
  • Serve as internal consultant on regulatory issues such as recalls, advertising and promotional activities, field actions or review of proposed device changes.
  • Maintain compliance with FDA, GMP/QSR, and ISO manufacturing process/work instructions

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    REQUIREMENTS:

    • BS/BA in business administration or related field
    • 5-8 years of external regulatory audit, compliance remediation
    • Working knowledge and understanding of FDA Regulations
    • Ability to use regulatory knowledge to identify critical compliance issues
    • Interact and communicate with Senior Management effectively
    • Effective verbal and written communication skills
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    • Certified compliance professional is a plus

Keywords: Cameron Craig Group, Columbus , Manager of Regulatory Affairs, Executive , Columbus, Ohio

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