Compliance Representative
3 weeks ago
Main tasks as a Quality Assurance and Regulatory Affairs Specialist is to understand the EN 13485/ ISO 13485, MDSAP, CE MDR Medical Device Class I and Class II and all subcategory related standards that apply to our products. You will be performing tasks as listed below:
· Qualify Supplier evaluation and documentation
· Monitor RMAs
. Monitor Complaint and Categorize them.
. Monitor On time Delivery, Frequency of Complaints
· Post Market Surveillance, Customer Feedback and Vigilance reports
. Monitor RMAs and Complaints
· Oversee medical and clinical trial publication documents
· Create SOP flow charts and Quality Test Document
. Generate ECNs
. Keep up to date Design History Files
. Keep up to date Device Master Record
. Keep up to date Document control files.
. Interface with Notified bodies and ISO 13485, MDSAP and CE auditors
. Schedule Audits
. Generate and keep up to date Risk Management documents per product Line.
. Keep up with European representatives.
· Interface with management for Adverse Event Reporting
· Conduct Internal audits and documentation
· Assist in Compliance Documentation editing, Copying, Sending, Notarization and Apostille Services
. All other Quality Control Related Tasks not listed above.
· Handle other unexpected tasks that are presented and assigned to you.
· Job Type: Full-time, In person 8:00 AM to 5:00 PM
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Company DescriptionMicro Medical Devices Inc. is a state of the art Ophthalmic Instrument medical Device Company dedicated to bring Eyecare health service devices to a worldwide diverse demographics. We serve medical professionals and world mission groups in providing eye care services to those in need.Company DescriptionMicro Medical Devices Inc. is a state of the art Ophthalmic Instrument medical Device Company dedicated to bring Eyecare health service devices to a worldwide diverse demographics. We serve medical professionals and world mission groups in providing eye care services to those in need.
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