Senior Director, Regulatory Affairs
Stryker - ENTERPRISE
Robert Lally BSc, MBA, C.Eng MIMechE, Senior Director Regulatory Affairs and Labeling, Stryker Joint Replacement, New Jersey.
From a background as a mechanical engineer in the petrochemical industry Rob moved into the engineering insurance inspection business responsible for safety inspection of elevators, escalator and lifting equipment and managing teams of 30 or so inspectors.As part of risk mitigation services Rob transitionned into advising clients on implementation of quality management systems and created some of the first QMS sector schemes focused on product and system integrity before creating one of the first medical device Notified Bodies in Europe.
Rob was subsequently Senior Consultant with Quintiles, became Head of BSI NB and then Director of European Compliance with J&J before relocating to USA to become Director Regulatory Affairs at J&J Vistakon. In USA Rob became focused on implantable devices (EU Class III) as VP Regulatory Affairs, Quality and Clinical at STAAR Surgical, then at Smiths Medical and later with CeloNova before becoming Senior VP Regulatory Affairs at BTG plc. Since 2016 Rob has been Senior Director Regulatory Affairs and Labeling at Stryker Joint Replacement and is their Division Program Lead for transitionning to the European Medical Device Regulations - he has a team of around 40 based in USA, UK and Ireland and works closely with international regulatory colleagues in Europe, Korea, Japan, China, Latam and Australia.
Tuesday, September 24
4:00 PM – 5:30 PM