Providing strategic direction for the Global Medical Device business of TÜV Rheinland International GmbH. Focused on new markets, growing markets, smart testing for clinical utility and new technologies including the proliferation of wireless and inter-connected devices as well as the wider cybersecurity issues related to healthcare IT systems.

www.enigmadiagnostics.com

Head of Medical Notified Body (Strategic Operational and Quality Assurance Role) Reporting to the Senior Vice President of Health Sciences Business, responsibilities include:Participant in the Global Strategic Management team matrix responsible for setting the direction of UL's Health Sciences business and determining the strategy and tactics for service line development, mode of delivery and continual improvement (effectiveness)Leading the development and execution of UL's Health Sciences Operational Quality strategyPlanning, delivery and periodic review of effectiveness of UL's certification service lines including ISO9001, ISO13485, Medical Devices Directive (93/42/EEC as amended by 2007/47EC), In Vitro Diagnostic Medical Devices Directive (98/79/EC), FDA, CMDCAS (Canadian requirements), PAL (Japan) and TCP (Taiwan).Creating, maintaining and developing Medical Devices Notified Body and In Vitro Diagnostic Medical Devices Notified Body QA system according to ISO9001, UK Competent Authority requirements (MHRA, Guidance 6) and UL Health Sciences Business needs.Most Responsible Person and point of contact for UK Competent Authority (MHRA) for all matters relating to UL's designation as Notified Body, including audits of the Notified Body and UL representation at Notified Body/MHRA/Industry tri-partite meetings.Keeping abreast of ongoing developments in global medical device regulations and incorporating these into the relevant UL processes.Key Account management - global client base.Management of 5 key Notified Body staff in the UK office.Setting, monitoring and meeting cost budgets.