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