Quality And Regulatory Affairs Specialist
CurrentResponsible for Regulatory Affairs and Quality Assurance needs for Clinician's Choice Group of Companies. Maintain and ensure the company quality system meets FDA, Health Canada, ISO 13485 and all international market medical device regulations.Specific responsibilities include:- All tasks that fall under the ISO 13485 standard.- Ensuring the Quality Management System is in compliance with ISO 13485 in addition to the medical device regulations for Canada (CMDR), USA (FDA) and Europe (MDD 93/42/EEC).- Coordinate and monitor all corrective actions. Investigate and analyze customer complaints and non-conformance issues in order to provide monthly reports and note any trends.- Administer ISO training to all new and existing employees. Ensure training logs are current for all staff and consistent with job descriptions.- Organize and implement the internal quality audit program according to a published and approved schedule. Ensure audits incorporate CMDR, FDA and MDD 93/42/EEC regulations for medical devices and that auditors are qualified to audit specific processes accordingly. Evaluate findings and implement appropriate corrective and preventative actions.- Assist in the development and documentation of standard operating procedures and current best practices. - Prepare, coordinate and assist in annual ISO 13485 CMDCAS, MDD 93/42/EEC and FDA surveillance and re-registration audits.- Prepare submissions for new products and line extensions to all appropriate governing bodies.- Assist in annual licence and establishment renewals.- Monitor changes to regulatory environment. - Conduct post-market reviews for all product families, including risk management activities as per ISO 14971.- Prepare reports for recalls and mandatory problem reporting.- Prepare, coordinate and assist with Health Canada Establishment inspections, FDA Establishment inspections and MDD 93/42/EEC unannounced audits.
