Regulatory Affairs Professional
Marsh Talent Consulting - Cleveland, OH

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We are looking for a Regulatory Compliance Professional for a client in the Cleveland, Ohio area. This professional will help to implement domestic and international regulatory strategies including preparing, coordinating and compiling product applications to regulatory agencies.

RESPONSIBILITIES

  • Perform HHE evaluations for field action decision-making and complaint investigations as needed.
  • Responding to inquiries or complaints from customers, regulatory agencies, or members of the business community.
  • Participate in customer complaint reviews to ensure global regulatory compliance.
  • Support Director during market actions and inspections/audits by FDA, notified bodies, or other regulatory body.
  • Manage FDA Establishment Registration process and medical device listings maintenance.
  • Prepare, submit and manage submission documents to regulatory authorities.

REQUIREMENTS

  • Bachelor degree in engineering or other technical or scientific field of study. The equivalent combination of education and experience may be considered.
  • Solid understanding of ISO 13485, ISO 14971, ISO 62366, IEC 62304, IEC 60601-1
  • Experience working in a regulatory affairs/compliance role within the medical device industry is preferred.