Compliance Representative

3 weeks ago


Calabasas, United States Medical Device Company Full time $30 - $35
Job DescriptionJob Description

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

·

 

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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