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Valentine Anyaibe
Regulatory Affairs Associate @ECI
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WORK HISTORY
Regulatory Affairs Associate @ECI
Boston, MA, US
Prepare and coordinate activities for 510k/De Novo/IDE/PMA (US) and Technical Files/ Design Dossiers (EU) submissions for medical devices • Responsible for FDA/ISO/MDD/CMDR compliance documentation • Generate regulatory documentation to be submitted to regulatory agencies in order to secure approvals to market products. • Performs predicate research for medical devices • Performs research and assists in defining regulatory and clinical strategies • Assists in special projects as needed. • Contributes to team effort by accomplishing related duties as requested. • Supports engineering changes through RA/QA practices by documenting the changes in compliance with the Quality Systems Regulations • Support Post Market Surveillance activities such as CAPA support, post market risk management, recalls, and complaint handling. • Supports engineering changes through RA/QA practices by documenting the changes in compliance with the Quality Systems Regulations • Represents regulatory function on cross-functional product development and manufacturing support teams. Guide teams to provide content for US and/or International submissions, participates in design reviews as needed. • Participate in project development teams and review plans, reports, risk management and design reviews associated with product and process project
EDUCATION
Massachusetts College of Pharmacy and Health Sciences
Doctor of Pharmacy - PharmD, Pharmacy
Certified Clinical Research Professionals Society (CCRPS)
Clinical and Industrial Drug Development
ABOUT VALENTINE ANYAIBE
Regulatory Affairs/ Drug Safety Associate with a demonstrated history of working in the management consulting industry. Skilled in Negotiation, Medical Devices, Pharmacovigilance, Pharmaceutical Policy, Management, and Healthcare. Strong professional with a Doctor of Pharmacy - PharmD from Massachusetts College of Pharmacy and Health Sciences.
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