Personal Information
Organization / Workplace
Greater Boston Area United States
Occupation
Regulatory Affairs Specialist - Companion Diagnostics (CDx)
Industry
Medical / Health Care / Pharmaceuticals
About
A pharmaceutical/medical device professional with expertise in regulatory (FDA,GLP, ISO) compliant environment. Experience includes project logistics, monitoring phases of both pre-clinical and Class II-III medical device projects for research and design development, data-integrity review and archiving in support of regulatory submissions of drugs and medical devices for the FDA (Food and Drug Administration). Strengths include attention to detail, organization, leadership and customer-leverage across all levels of organization.
Contact Details