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Personal Information
Organization / Workplace
Vancouver, Canada Area Canada
Occupation
Associate Researcher
Industry
Medical / Health Care / Pharmaceuticals
About
Orthopedic devices researcher with 3-year experience in an industrial research/service organization. Experienced in the product realization process, FDA 510(k) clearance, quality system and pilot production in the Biomaterial Production GMP. Strong analytical, logical thinking and detail-oriented. Specialties: •ISO 13485, 10993, 14971 •Quality System Development •Research/pilot Plant Management •Risk management, control and analysis •Negotiation with regulators •Minimally invasive surgical procedures •Implantable devices
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