Sullivan Ferrari Email & Phone Number

Partner with sales and business development teams to understand the needs of prospects, influence strategy and product roadmapServe as an internal champion in bringing R&D, Operations, Regulatory, Manufacturing, Sales and other functions to respond to customers and prospects with a sense of urgencyLead onboarding process and trainingResolve customer.

Ensure QMS compliance with ISO 13485:2016, ISO 9001:2015, FDA 21 CFR and product regulationsGuide QA/RA strategy to match business opportunitiesSmall team managementManage ANSM declaration / FDA device registration and listing Regulatory changes tracking

Managed QMS compliance with standards ISO 13485:2016, ISO 9001:2015 & products certifications including CAPA, PMS and RMA management, Quality control definition, Management review,Audit (client, notified body, supplier, internal) managementManaged CAPA process with major MedTech companies

Managed product life cycle (design inputs to PMS) and worked on software development. FDA class I medical device linked to FDA class III pacemaker remote monitor (Medtronic CRHF)

Led Software Design for device part of an integrated CGM system (insulin pump, sensor, portable device and backend application). Managed co-development with customer (Medtronic Diabetes)

Embedded Software development for IoT platform and Remote Patient Monitoring solutions

Managed business applications development (pricing scheme, internet/extranet/intranet, etc)