Anthony Sirgi Email & Phone Number

Montreal, Quebec, Ca

Leading Regulatory Affairs and Quality Management team (as Management Representative) to ensure compliance to applicable medical device ISO standards (ISO 13485, 14971 etc.) as well FDA, Health Canada and EU Regulatory requirements. Implementation of cGMP requirements from the ground up in a timely manner. Responsible for successful filings of 510(k) Traditional, Technical File and Health Canada Class 2 Medical Device License. Leveraging foreign market regulatory requirements to ensure best regulatory pathway for the organization. Ensure continuous improvement by challenging status quo and working with cross-functional team to ensure effectiveness of processes.

Yardley, Pa, Us

Implemented Quality SystemManage Recalls of medical devicesSubmit mandatory problem reports to Health CanadaEvaluate and file medical device license amendments with Health CanadaManage the organisation's training databaseReview promotional materialCreate SOP's and WI'sCertified ISO 13485:2016 Lead AuditorParticipated in Health Canada AuditCreate Change ControlsApprove reworksExperience in using Salesforce Experience in using SAP