Job Details

TEEMA


Quality Control Regulatory Affairs Compliance Co-ordinator


Quality Control Regulatory Affairs Compliance Co-ordinator Our client designs, develops and manufactures laser equipment for cancer treatment and therapeutic uses. The client is certified to ISO 13485. They are seeking a productive, experienced RA Compliance Co-ordinator who is creative and has excellent problem solving abilities.Responsibilities will include:Meet regulatory requirements and compliance with FDA, EU MDDs, preparations, submissions, and post marketUpdate the QMS and lead the transition to the ISO 13485:2016 MDSAP standardEnsure the company is fully compliant with ISO 13485:2016, Medical Device Directives,Canadian Medical Device Regulations and FDA CDRH.Prepare regulatory submissions for FDA, CE Mark, Health Canada approvalsPrepare for internal audits and inspections and lead ISO audits and FDA inspectionsPrepare for quarterly CSA audits and interface with CSA auditors.Responsible for the review, control and release of documentation and records in support of thequality management system including maintaining the design history file, device history recordsand device master records.Develop quality metrics and provide analysis to support continuous improvement of product andprocessesOwn the CAPA process and implementation of corrective action both internally and as requiredwith suppliersSupport Production as needed when Quality duties are light.Qualifications:MUST HAVE:5+ years’ experience in a Quality Assurance / Regulatory role in a Medical Device Manufacturingfacility under ISO 13485Record of successful regulatory submissions to the FDA, Health Canada, and CE markapplicationsExperience leading internal audits, ISO audits, and FDA inspections.Experience in Risk Management – ISO 14971Willingness to work with production when things are slow in Quality/RegulatoryNICE TO HAVE:• Certified Quality Engineer CertificateJob Type: Full-time position, reporting to the V.P. of Engineering Job Location: Toronto, ONRequired education: Regulatory Affairs Certificate

Job Category:  [ View All Jobs ]
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Experience (years): Unspecified
Job Location: USA
Posting Company Type Employer
Post Date: 04/09/2018 / Viewed 672 times
Contact Information
Company: TEEMA


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