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Charles Tam
Regulatory Affairs, Medical Devices
Hi, I'm Charles Tam. Welcome to my profile!
Charles Tam's Bio:
Charles Tam's Experience:
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Regulatory Affairs Manager at Abbott Vascular Canada
October 2011 - May 2014- Leading the Canadian affiliate Regulatory Affairs, Regulatory Compliance, Quality Management, Environmental Health & Safety (EHS), Office of Ethics & Compliance (OEC) functional areas. - Additional responsibilities include interim leading of affiliate Operations (i.e. Warehouse, Customer Service, etc.) and leading as internal Canada IMDRF (International Medical Device Regulator's Forum) representative for the division. - Managing and coaching a high-potential Canadian regulatory team with an emphasis on fostering long-term development, mentoring individuals and developing towards robust succession planning. - Liaising across internal and external stakeholders on compliant and effective strategic guidance to global cross-functional project teams to negotiate coming Canadian regulatory challenges. - Partnering with Health Canada to negotiate positive outcomes, such as improved submission timelines, Special Access Program (SAP) and on-going compliance solutions. - Building and expanding the professional relationships between inter-company and external partners to drive for successful collaborative proactive results. - Leveraging experiences and technical knowledge to assist the Global Regulatory Affairs teams in gaining timely Class III & IV approvals for key high-risk products (including drug/device combination products). - Facilitated successful Priority Review acceptance of a high-risk Class IV cardiovascular medical device new licence application. - Ensuring Canadian regulatory requirements are included early in the planning processes and strategy development to streamline divisional-level processes for greater efficiencies and faster results. - Developing and implementing process improvements that enabled cost and time-savings through gained efficiencies, expertise sharing, shared-resource leveraging and a team-based approach. - Actively representing Abbott Vascular Canada regulatory interests on the Regulatory Affairs Committee (RAC, formerly RASC) at MEDEC.
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Regulatory Specialist at Johnson & Johnson Medical Companies
August 2010 - October 2011- Responsible for coordination of national-scale regulatory activities including complex Medical Device Licensing, Pre-market Strategy and Recalls for multiple franchises. - Proven success in negotiating complex submission strategies and regulatory compliance requirements with Health Canada. - Identified, implemented and executed process improvements for the Health Canada Annual Renewals, resulting in significant company savings in Q4 2010. - Experienced in compiling high-quality Class III & IV Medical Device Licence Applications/Amendments, submission of Quality System Certificates and managing Establishment/Site Licences. - Established track record of "first-pass success" for regulatory submissions with no Health Canada questions. - Lead regulatory liaison on project teams to proactively ensure that products, advertising and labelling comply with applicable regulations and policies. - Industry representative of J&J at the MEDEC Regulatory Affairs Steering Committee (RASC) and MEDEC RASC Sub-Committee on Environmental Protection.
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Regulatory Affairs Senior Associate at Becton Dickinson Canada Inc. (BD-Canada)
August 2007 - July 2010- Twice promoted into progressively senior roles starting from Accounts Management (Customer Service - Key Distributors Accounts) to Associate, Regulatory Affairs to Senior Associate, Regulatory Affairs within 3 years. - Successfully coordinated national-scale compliance activities including Medical Device Recalls, Mandatory Problem Reporting, Adverse Event Reporting and Audit Management. - Lead Canadian representative on various Global Company Initiatives including Worldwide Vigilance, EU REACH and Chemical Substance workstreams. - Proven success in negotiating both submission strategies and regulatory compliance requirements with Health Canada. - Experienced in compiling and managing successful Natural Health Product (NHP) Transitional DIN Applications, NHP Non-traditional DIN Applications, Medical Device Licence Applications/Amendments, managed all CMDCAS Quality System Certificates, Establishment and Site Licences. - Proven technical expertise as departmental SAP Superuser, Cognos Data-steward and other in-house ERP systems. - Trained as back-up Radiation Safety Officer (RSO) in compliance with CNSC requirements. - Industry representative of BD-Canada on the MEDEC Regulatory Affairs Sub-Committees on Post-market Vigilance and Environmental Protection.
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Bilingual Customer Service Representative at Becton Dickinson Canada Inc. (BD-Canada)
August 2006 - May 2007- Managed key national customer accounts for authorized distributors and regional direct hospital customers across Canada (incl. Quebec). - Served as the departmental Business Intelligence lead via functional responsibilities as the SAP Super User and Cognos Data Steward. - Identified as a high-performer by BD HR and participated in an internal cross-functional talent management and development program towards a transition into the Regulatory Affairs department.
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Research Assistant & Laboratory Technician at University of Toronto
March 2006 - August 2006- Led and coordinated a research sampling analysis in a biodiversity field study seeking to model population distributions in disruptive environments. - Continued on a part-time (evenings and weekends) basis from Aug 2006 until Aug 2007 to oversee laboratory assessment and to ensure successful study research outcomes. - Managed and coached a team of undergraduate volunteer researchers towards successful project completion. - Developed and maintained strong professional team working relationship with colleagues, professional researchers and fellow researchers.
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Regulatory Affairs Senior Manager at Edwards Lifesciences
May 2014- Leading the Edwards Lifsciences' Regulatory Affairs Strategy in Canada, Canadian Regulatory Projects representative in the International Region and lead for preemptive Regulatory Compliance. - Managing, coaching and oversight of the Canadian Regulatory Affairs and Compliance team. - Primary Health Canada liaison for Medical Devices on Priority Review, Device Licensing, Establishment Licensing, Special Access Program & Investigational Testing Authorizations (ITA). - Actively representing Edwards LIfesciences (Canada) regulatory interests on the Regulatory Affairs Committee (RAC, formerly RASC) at MEDEC, Canadian Medical Device Technology Industry Association.
Charles Tam's Education:
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Ryerson University
2011 – 2015MBA -
University of Toronto
2002 – 2006B.Sc (Hons)Concentration: Biology, Environmental Science
Charles Tam's Interests & Activities:
Regulatory Affairs, Regulatory, Compliance, Quality, Medical Device, Medical, Healthcare, Health, Technology, Charles Tam, Canada, Health Canada, Submissions, Regulatory Intelligence, Regulatory Strategy, Regulatory Tactics, Regulatory affairs, regulatory strategy, regulatory intelligence, regulatory compliance, trade complaints, medical devices, in-vitro diagnostic devices, implantable devices, natural health products, combination products, submission planning, special access, significant change, strategic execution, negotiations with regulators, influencing stakeholders, ISO 13485, CMDCAS, quality systems, procedure writing, adverse events, CMDSNET Sentinel pilot, post-market vigilance, recalls, government liaison, life-science research, general laboratory, biological sciences, environmental stewardship and environmental reporting (i.e. ESABC, EPRA).