Sr. Regulatory Affairs Specialist Medical Devices
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Experienced and adaptable professional with experience in biochemical, analytical and technical fields with strong quality assurance and regulatory knowledge, effective interpersonal and organizational skills. Knowledge in the Medical Device Regulatory Affairs, International Product Registrations, and Quality Control Procedures, US FDA Facility Registration and Listings, Regulatory Information Management, and medical device labeling requirements.
Experienced and adaptable professional with over 15 years of experience in medical device, analytical, and technical fields with strong Regulatory and Quality assurance, and effective interpersonal and organizational skills.
Experience with 510(k), EU Technical Documents, and International STEDs, Design changes and NPD for regulatory considerations. Working within the requirements of 21 CFR 820, ISO13485, the Medical Devices Directive/MDR (93/42/EEC) for Class I, II and III devices and/or the IVD Directive (98/79/EC).
Public.
Experience in US FDA regulatory submissions, including 510(k)s, PMAs and PMA Supplements. International regulatory submissions and product registrations in LatAm, Canada, EU, A/NZ, Japan and APAC and Global UDI compliance. Reviewing design control documents including documents associated with design inputs and design output, prepares and coordinates product registration packages.
Masters of Public Health- Southern New Hampshire University
