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.
- 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.
- 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.