David Conrad Email & Phone Number

Paris, Fr

Paris, France

Responsible for Post-Market Regulatory Affairs activities for Northern and Central Western Europe (18 countries).People management and development of key capabilities. Strong ability to manage through change and in highly matrix environment.Primary contact for national regulatory authorities, acting as EU Authorized Representative (EU AR) and Person Responsible for Regulatory Compliance (PRRC) to the EU AR.Management of Post-Market Surveillance queries from regulatory agencies for the whole company portfolio across all business units.Regulatory partnership and support to business objectives and product launches.Regulatory Intelligence and Advocacy.Divisional Regulatory support for Interventional Cardiology, Structural Heart, Peripheral Interventions.Direct liaison with cross-functional stakeholders at Divisional and Corporate level.Coordination and support to in-country regulatory teams of activities and responses to complex and/or business critical issues that require strategic alignment and consistency in actions throughout EMEA.Strategy and coordination of execution of Post-Market Surveillance programs and Field Actions.Regulatory Core Team member for new business Acquisitions integration.Regulatory support to Notified Bodies audits.Management process optimization and harmonization, support to Value Improvement Projects.Regulatory support for Clinical Affairs.Regulatory Core Team member for Global clinical investigations programs (pre- and post-market). Interface between global cross functional and in-country regulatory teams for the management of all regulatory aspects of clinical projects.Regulatory Intelligence and Advocacy at EU level.

- Successful implementation of full Quality Management System and certification against the European Medical Devices Directive 93/42/EEC, US FDA Quality System requirements and ISO 13485 standard.- Successful management of recertification Notified Body audits, including responses to findings.- Responsible for the quality and regulatory aspects of new product design control, testing and product release.- Selection and qualification of vendors, and management of audits to ensure they achieved compliance with quality, regulatory and product specifications. - Regulatory submissions for CE marking and support to US FDA 510(k) files.- Management of all post-market regulatory activities (all products).- Collaboration with distributors to secure timely product registrations in line with company business growth plan.

- Successful implementation of full Quality Management System and certification against European Medical Devices Directive 93/42/EEC and ISO 9001, EN 46001 standards.- Successful management of recertification Notified Body audits.- Regulatory submissions for CE marking and US FDA 510(k) files.- Development of manufacturing activities in clean room environment, sterilization process validation, employee training on good manufacturing practices. Co-led the transfer of manufacturing activities from France to a site in the USA.