Rik Davidson Email & Phone Number

Recognized leader with extensive management experience in Regulated industries. Bringing value to the organization through:- Market access and maintenance in +100 Countries. - Increasing Global Compliance with Regulatory Intelligence- Establishing and maintaining a high trust, positive work culture- Managing, growing teams and developing individuals- Relationships with Trade Associations and networking in Government Affairs Excellent communication and inter-personal skills I am comfortable working at all levels of the organization. Happy to roll up my sleeves, provide oversight or be an agent of change. High analytical and problem solving skills mixed with the ability to execute on a companies multi-year vision make me your ideal partner to achieve success. Key words:- Medical Devices (MDs) all classes & Technical Files- In Vitro Diagnostics (IVDs)- Software as Medical Devices (SaMD)- Person Responsible for Regulatory Compliance (PRRC) - Europe (EU), Middle East, Africa (EMEA), CIS, Latin America (LATAM) - Managing Cross functional, Inter-departmental, External partners- Distribution Agreements, Quality Agreements - Regulatory process, Strategy & Policy- Regulatory intelligence: Legislation (Regulations & Directives), Standards, Guidance documentsExternal groups:- MTE Corporate Council (MD, IVD)- MTE Europe Regulatory Affairs Committee (MD, IVD RAC)- MTE Chemicals WG- MTE Hazardous Substances WG- MTE Blood Tissues & Cells WG- MTE Labelling WG- Blood Transfusion Association (BTA) founding member- ABHI MD WG & IVD WG- EU Transparency register- UK MORE database- Member of Team PRRC

Listed skills include Fda, Gmp, Capa, Validation, and 29 others.