Martin Banda

About Martin Banda

As a Regulatory Affairs Strategist with over 10 years of experience in the medical device…

Experience

1. Regulatory Affairs Manager, Compliance

   BD

   Feb 2021 — Present

   Provides regulatory leadership to platform teams, providing regulatory guidance throughout the product development lifecycle and coordinating inputs for regulatory submissions, responses and corrective actions. Regulatory Lead responsible for Interpretation, assessments and execution of changes to meet European regulatory requirements such as 745/2017 EU MDR Process Owner management of documents of external origin -DEO (Regulations, Standards, Directives, Guidance Documents etc.) Activities include Sensing, Influencing Assessing and implementing DEOs. Responsible for tools, procedures, approaches and methodologies to address new legislations, regulations and guidance documents. Regulatory Affairs Remediation lead (includes NC reviews, CAP responses, CAPAs functional representative, Business Unit CAPA board member) Responsible for providing regulatory guidance on registration of products and interact as necessary with the U.S. regulatory agencies and Notified Bodies Responsible for Quality Systems integration/harmonization strategies related to regulatory processes (Technical Documents, UDI, regulatory assessments etc.) Responsible for elements of regulatory compliance, impact and strategy implementation (situational analysis, recalls, field actions etc.). Responsible for audit management (regulatory lead front-back room audit activities for internal and external audits)