David Telling

A Senior Quality & Regulatory Director for the Medical Device industry in Europe benefiting from more than 35 years’ experience in various Quality roles, with the last 18 years in senior management positions within the MedTech environment.

Offering pragmatic Quality & Regulatory solutions to system development and remediation projects based upon a “can-do” approach.

Experience

• ELIQUENT Life Sciences – Partner – Medical Device QA/RA
• ELIQUENT Life Sciences – Multinational Pharmaceutical Manufacturer (United States) – Medical Device SME
• ELIQUENT Life Sciences – Multinational Device Manufacturer (United Kingdom) – Acting Quality Director, Project Lead MDD Remediation
• ELIQUENT Life Sciences – Multinational Device Manufacturer (United Kingdom) –Dutch Ophthalmic Research Center (Netherlands) – Acting Quality & Regulatory Director
• Dutch Ophthalmic Research Center (Netherlands) – Project Lead FDA Readiness
• Smith & Nephew (2004 – 2017) – VP Quality Assurance/Downstream Quality Director EU ANZ/UK & Germany Quality Director/UK Quality Director

Projects

• Multinational Pharmaceutical Manufacturer (10 Months) – Adoption of a Medical Device into the exiting Pharmaceutical QMS and subsequent preparation for initial and  follow-up MDSAP Notified Body audits
• Medical Device Manufacturer (12 Months) – management of all quality processes including design control, Complaint Handling, Vigilance reporting, documentation, quality planning, CAPA and deviations Preparing & hosting Notified Body ISO13486:2016 & MDSAP audits (post remediation)
• Medical Device Manufacturer (18 Months) – Project Management of a significant MDD & MDSAP remediation project including recruitment / vetting of additional SME resources as necessary to achieve project goals including risk management, sterilization validation, procedural development, design file improvements and training. Writing and/or re-writing procedures where appropriate SME support not available.
• Dutch Ophthalmic Research Center (10 Months) – Management of all Quality & Regulatory processes including. validation, design control, Complaint Handling, Vigilance reporting, Global Product registrations and submissions. Preparing and hosting Notified Body ISO13486:2016 /  MDSAP audits and FDA Inspections (US)
• Dutch Ophthalmic Research Centre (15 Months)  – Project Management of a significant FDA readiness project including identification and secondment of internal staff to appropriate tasks. Reporting of project status to the Board of Directors.