Michael Pignataro Email & Phone Number

Las Vegas, Nevada, United States

Palo Alto, CA

• World’s leading manufacturer of medical devices and software for treating cancer and other medical conditions with radiotherapy, radiosurgery, proton therapy, and brachytherapy. Annual revenue +$3BReporting to.
• Provided clinical input and review of all post-market customer recall notifications.
• Reviewed and approved marketing materials/labeling as member of global marketing communications team
• Prepared Food and Drug Administration MedWatch (MDR) Reports; Health Canada Medical Device Problem Reports (MPRs); and EMEA Vigilance Reports. Compiled and prepared technical and risk management materials for.
• Clinical advisor for post-market Corrections and Deployment Management Team. Maintained current knowledge base of existing and emerging regulations, standards, and guidance documents

Palo Alto, CA

• Reporting to Vice-President, Regulatory Affairs and Quality Assurance, directed team of 6 reporting specialists and project managers responsible for all aspects of post-market corrections and removals.
• Firm signatory for customer notifications (PNL/FSN), MedWatch, Vigilance (EMEA) and MPR (Canada) Reports, as well as Corrections and Removals (21 CFR 806) Reports and updates.
• Served as a member of risk management and legal review team.
• Organized and managed over 40 recalls with and for senior executive management. Performed annual reviews, salary planning, and recruiting.

Las Vegas, Nevada Area

• Reporting to Senior Manager Clinical Training for the Americas
• Trained internal and external customers in all aspects of product operations for linear accelerator equipment, treatment planning, and medical records hardware/software systems
• Managed 15 direct reports, including annual reviews, salary planning, and recruiting/hiring.
• Conducted orientation sessions and arranged on-the-job, classroom, simulations and scenario-based training for new hires and veteran employees, targeting skills for improvement
• Supported curriculum development in a creative, dependable, and flexible manner to improve programs, including updates to materials and protocols.
• Supported onsite and trade show clinical trainings.

Las Vegas, Nevada Area

Greater Chicago Area

• Taught/prepared Radiation Therapy (RT.T.) students in Site Specific Cancers, Radio Biology, Medical Terminology and Psychology of Radiation Therapy.
• Recruited and instructed student therapists in a large urban hospital clinical and classroom settings.
• Organized and began the program to successful accreditation by the JCERT national accrediting organization.

Tucson, Arizona Area

Los Altos Hills, CA

• Preparing student therapist for board certification (RT.T.); including evaluation of students’ technical skills and performance interacting with and treating patients in clinical-affiliated settings.
• Responsibilities included recruiting student therapists and maintaining clinical affiliations at Stanford University Hospital, El Camino Hospital, Santa Clara Medical Center, and Good Samaritan Hospital in the Bay Area.

Associate Of Arts And Sciences (Aas), Radiation Therapy

Bachelor Of Applied Science (Basc), Criminal Justice And Corrections

Master Of Arts (M.A.), Adult And Continuing Education And Teaching