Senior Regulatory Lead job opportunity at Synthesia.

Home Jobs In Canada Tag: Regulatory Senior Regulatory Lead position at Synthesia


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Synthesia Senior Regulatory Lead
Experience: 3-years
Pattern: full-time
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Regulatory

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degreeBachelor's (B.Sc.)
loacation Vancouver, Canada
loacation Vancouver....Canada

#Regulatory Management : #Leads regulatory compliance activities for all medical device products working closely with Product #Managers for creation and maintenance of compliant DHF and Technical files. Manages all medical device establishment registration and medical device product licensing with regulatory authorities ensuring timely filings and compliant status. Prepare and coordinate content of all pre-market regulatory submissions in all markets, monitor status, drive timely responses, and ensure project deadlines are met. Review product labelling for compliance and advice on meeting applicable standards Establish and maintain relationships with authorized representatives Manages change control process including regulatory classification of new and updated products and notifications of significant changes to regulatory authorities. __ Support Complaint Handling Unit Remains up to date on applicable regulation and standards including #FDA (21 CFR 820); Health #Canada MDR; UK MDR, #EUMDR. #Maintain familiarity with our products and solutions. Work with Product, Service, and Quality to submit post-market surveillance plans and reports Provide regulatory support during third-party audits of the QMS Keep up to date with changes in relevant regulatory changes and guidance. Train teams on relevant FDA, Health Canada, and EU regulations and guidance.
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