Module 17 2024

27/11/2024

The Role of the RA Professional

Q. What do we do?

…..Write submissions and Get approvals

The Organisation for Professionals in Regulatory Affairs

Lecture 1

3

The Role of the RA Professional

Writing submissions Obtaining approvals

Additional Roles: QA

Identifying requirements Interpreting requirements Determining regulatory strategy and timelines Reviewing documents e.g. test reports Writing key documents e.g. CERs Participating in/ leading key processes: - Risk management - Vigilance Auditing

Technical

AR

Clinical

PRRC

Commercial

Representing the company: Conferences Manufacturer associations Professional associations Other activities: Standards work Regulatory due diligence

Liaising with regulatory bodies Addressing non conformities Maintaining CE certification Providing Training

The Organisation for Professionals in Regulatory Affairs

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2