Samantha C.
Regulatory Affairs Specialist / QMS Management Rep., at BEYES Dental Canada Inc- Claim this Profile
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English Professional working proficiency
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Chinese/Mandarin Native or bilingual proficiency
Topline Score
Bio
Credentials
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ISO 9001:2015 Internal Auditor
BRCMar, 2017- Nov, 2024 -
CQA-Certified Quality Auditor
ASQJun, 2015- Nov, 2024 -
ISO 14001 Internal Auditor
-Jul, 2014- Nov, 2024 -
ISO 13485:2003 Quality Management System Internal Auditor
-Dec, 2009- Nov, 2024 -
ISO 9000:2000 Series Auditor/Lead Auditor
-Aug, 2003- Nov, 2024
Experience
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Beyes Dental Canada Inc
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Canada
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Medical Equipment Manufacturing
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1 - 100 Employee
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Regulatory Affairs Specialist / QMS Management Rep.,
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Jul 2022 - Present
* Deliver Medical Device MDSAP, CE Marking and ISO 13845 scheme management.* Premarket- Assess the acceptability of technical files for submission filing.* Determine submission and approval requirement and compile, prepare, review and submit regulatory submission to various authorities.* Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.* Oversee advertising and promotion, labeling, restricted substances, Import / export· Country-specific regulatory support.* Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies / notified bodies.
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Philips
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Netherlands
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Hospitals and Health Care
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700 & Above Employee
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Quality/Regulatory Specialist
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Apr 2019 - Apr 2020
-Conduct peers review of regulatory submissions and provide constructive feedback to Regulatory Specialists and Associates.-Monitor the performance of medical device/consumer products after released to the market and ensure post-market surveillance plans and reports are completed and reported on time, including Recalls, MDPRs, Consumer Product Incident Reports.-Monitor, track, and communicate KPI progress to leadership. -Conduct peers review of regulatory submissions and provide constructive feedback to Regulatory Specialists and Associates.-Monitor the performance of medical device/consumer products after released to the market and ensure post-market surveillance plans and reports are completed and reported on time, including Recalls, MDPRs, Consumer Product Incident Reports.-Monitor, track, and communicate KPI progress to leadership.
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ZEISS Medical Technology
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Germany
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Medical Equipment Manufacturing
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700 & Above Employee
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QA/RA Specialist/ Carl Zeiss Canada Ltd.
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Jul 2016 - Sep 2017
-Compile and submit Class II /III licence applications /amendments to Health Canada. -Manage the maintenance and updating of Health Canada Medical Device listings, device licences, and establishment registrations/annual renewal.-Support the Operations and Compliance Manager in the preparation and responses to ISO 9001 internal audits and regulatory agency audits.-Monitor effectiveness of the QMS through Internal Audits, CAPA, customer complaints, and customer satisfaction survey.-Inventory and calibration control on Service measuring equipment.-Maintain and report on NPS(customer satisfaction survey) and facilitate initiatives.-Support manufacturer during ISO 13485 quality system audit and provide training for CMDCAS/MDSAP.-Successful pass the Health Canada MDEL inspection in 2016.
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Toshiba Tec Canada Business Solutions Inc.
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Canada
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Information Technology & Services
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1 - 100 Employee
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Regulatory Affairs and Quality Assurance Manager
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Apr 2011 - Jan 2015
--Establish and maintain internal regulatory Procedures& Processes to ensure that all related activities comply with the Food and Drugs Act and the Medical Device Regulations in Health Canada. --Compile and submit Class II and Class III licence applications and amendments to Health Canada. Obtain and manage Health Canada device licences and annual renewals.--Manage Canadian post-market/compliance activities, responsible for Customer Complaint Handling, Recall and MDPRs Reporting.--Successful pass the Health Canada MDEL inspection in 2012.
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Toshiba Medical Systems Asia
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Afghanistan
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Medical Equipment Manufacturing
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1 - 100 Employee
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Regulatory Affairs Manager
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Jul 2006 - Mar 2011
--Monitor markets for regulatory changes to applicable standards, regulations and regulatory agency requirements, and communicate changes and provide trainings across the organization, includes headquarter in NASU.--Develop and execute effective regulatory strategies for Class II, III and Class IV medical devices to meet and exceed business objectives.--Responsible for CT/X-ray /Ultrasounds/MRI on site ISO 13485-factory audit and product type test in NASU to ensure the processes and procedures comply with CFDA requirement.--Manage adverse event and recall processes including reporting adverse events, advisory notices and recalls to CFDA.--Management of communications with regulatory agencies and external partners, such as COCIR, JIRA and AHWP/GHWP.
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GE HealthCare
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United States
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Hospitals and Health Care
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700 & Above Employee
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Regulatory Affairs Specialist
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Mar 2002 - Jun 2006
--Compile for CT/X-ray/MRI licensing submission to CFDA, implemented ISO 13485 & ISO 9001 on-site factory audit in Milwaukee & San Francisco in 2003.--Responsible Nuclear licensing submission to CFDA, implement ISO 13485 & ISO 9001 on-site factory audit in Haifa, Israel in 2003.--Handle Recall, Adverse Event Report and resolve the post-market surveillance issues. --Compile for CT/X-ray/MRI licensing submission to CFDA, implemented ISO 13485 & ISO 9001 on-site factory audit in Milwaukee & San Francisco in 2003.--Responsible Nuclear licensing submission to CFDA, implement ISO 13485 & ISO 9001 on-site factory audit in Haifa, Israel in 2003.--Handle Recall, Adverse Event Report and resolve the post-market surveillance issues.
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Regulatory Affairs & Marketing Specialist
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Mar 2000 - Mar 2002
--Electron Beam CT imaging systems CFDA & CCIB licensing application. --Marketing promotion.--Translator. --Electron Beam CT imaging systems CFDA & CCIB licensing application. --Marketing promotion.--Translator.
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General Affairs Office
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Jul 1996 - Feb 2000
--Perform survey on sensitive urban issues in China, reviewed and drafted Survey Reports which were aired in the Weekly Investigation of Financial Report at 7:15 of every Tuesday on CCTV;--Involve in developing Economic Pre-Alarming System and Economy Prosperity Indexes for publica nationwide;--Organize and hold national economy forums. --Perform survey on sensitive urban issues in China, reviewed and drafted Survey Reports which were aired in the Weekly Investigation of Financial Report at 7:15 of every Tuesday on CCTV;--Involve in developing Economic Pre-Alarming System and Economy Prosperity Indexes for publica nationwide;--Organize and hold national economy forums.
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Education
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2011 - 2014
Seneca College of Applied Arts and Technology
Quality Assurance Certificate, ASQ-CQA -
2004 - 2007
Peking University
Bachelor of Arts (B.A.), Law -
2000 - 2003
Peking University
Bachelor of Arts (B.A.), Foreign Affairs Management and Foreign Secretary -
1994 - 1996
World Exchange College of Language
Diploma, Business English
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