Kenneth Jensen
Principal @RCI
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WORK HISTORY
Principal @RCI
Waterloo, ON, CA
RCI serves medical device clients in the following areas:• ensure implementation of medical device quality management system and additional regulatory requirements for the North American and European marketplaces (21 CFR ISO 13485+ISO 14971; EU MDR; CMDR);• comprehensive regulatory planning and submission development/filing; liaison with regulatory bodies for the duration of the submission/review process;• “cradle to grave” operational risk review of client activities as well as key/critical supply chain links;• formalization of company strategies for program management and control of outsourced processes as well as ensuring identification of and conformity to regulatory requirements for target markets.Services address fulfillment of endogenous and exogenous requirements for implantable and external devices and in-vitro diagnostic products, throughout the product lifecycle from initial concept through design/development and manufacturing, marketing release and postmarket activities. This may include process improvement for Management Review; review of product advertising and promotional material; CAPA process development and implementation including issues resolution and documentation; field actions and recalls; product obsolescence and removal activities, and appropriate document/records/data control and archival. Recent activities include comprehensive quality and regulatory services for the spin-off and sale of a new European robotic neurosurgery company (QMS establishment/certification and EU/US regulatory filings); ongoing divisional monitoring of quality and regulatory compliance for a global medical devices company (US, Canadian and European requirements plus MDSAP mock audits); facilitating the smooth incorporation of a recent acquisition into the overall quality system of the new global parent company; and, multiple compliance audits to support M&A activities.
EDUCATION
University of Toronto
Master of Engineering, Department of Chemical Engineering and Applied Chemistry
Western University
Bachelor of Science, Biology
University at Buffalo
Master of Science, Cell Biology
SKILLS
ABOUT KENNETH JENSEN
Regulatory affairs and quality management system leadership for the medical devices sector focusing on: • comprehensive regulatory planning, labeling review, submission preparation and regulatory liaison; • QMS implementation and compliance, facility and supplier oversight; • operational and product risk management (inclusive of all regulatory and QMS requirements); • audit/due diligence activities related to the above, including evaluations for M&A activities. Longstanding focus on: • comprehensive regulatory planning and execution, post-approval product management; • importance of Management Review (monitoring regulatory change/status and QMS operations); • supplier evaluation and management: contracts/controls/monitoring/audit; • appropriate application of risk management principles throughout the quality management system. Master of Engineering, Hazard Analysis and Risk Assessment – University of Toronto Master of Science, Hematologic Oncology – Roswell Park Cancer Institute/State University of New York Certifications: ISO 13485 - Lead Auditor; ISO 14971; ISO 9001 - Lead Auditor (not current) US Green Card holder (inactive/dormant); registered US CBP Trusted Traveler / NEXUS; Canadian citizen. Past recipient US DOE security clearance.#risk #riskmanagement #medicaldevice #audit #designcontrols #PMA #510(k)#EUMDR #QMS #quality #regulatory #management #compliance #duediligence #contract #consultant
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