Sonam Patel Email & Phone Number

Stirling, Gb

Stirling, Scotland, United Kingdom

- Coordinate international regulatory approval of Berlin Heart devices (CE, US, Japan market)- Liase with regulatory authorities and notified bodies regarding product approvals- Ensure timeley renewal of product licenses in international markets- Lead the approval of products under the new UK conformity assessment procedure

Berlin Area, Germany

In addition to previously mentioned responsibilities- Regulatory lead for the approval of two novel cannulae in the CE and USA markets

In addition to previously mentioned responsibilities-Quality lead responsible for the review and release of all production related validation and verification activities.

Berlin Area, Germany

- Ensured product vigilance by preparing succinct incident reports in case of product malfunctions for a variety of international vigilance authorities (FDA, BfArM, PMDA etc.).- Responsible for regulatory compliance of products across the international market through timely submission of product failure investigation reports to regulatory bodies- Ensured competent validation/qualification of organization-wide processes/equipment based on ISO regulations and statistical process control (SPC)- Supported CAPA activities

Miami Lakes, Fl

- Implemented a FDA 21 CFR Part 11 compliant Electronic Servicing report system to replace inefficient paper based reporting- Led remediation of internal audit non-conformities by qualifying servicing tools and internal complaints database to comply with FDA 21 CFR 820 Servicing standards- Nominated as Product Expert to ramp up understanding of product technical aspects within a 20 member emergency QA Taskforce established to address FDA Warning Letter (6 months)- Gained an accelerated understanding of quality assurance regulations and achieved the highest turnaround rate for completed Product Investigation Reports (~70 closed complaints within 3 months)

Emory University Hospital, Atlanta

- Designed input requirements and built a database of anatomical MRI scans from sensitive patient data- Customized the functionality of a proprietary measurement software to render 3D reconstructions of MRI scan images

Greater Philadelphia Area

- Developed a successful medical product commercialization plan - Performed primary and secondary market analyses

Drexel U

-Organized course scheduling, maintained class records, class website, and graded coursework. -Led monthly laboratory sessions to introduce students to the current research projects.- Led help sessions on a regular basis.

Dr.Lec'S Bionanosensors Laboratory, Drexel U

-Worked with a team of researchers and international collaborators, to design, build and test a rapid Point of Care diagnostic device for instantaneous diagnosis of cancer biomarkers. -Acquired biosensor development skills- Continually recorded developments in Device History File (DHF) based on FDA’s GMP for medical devices -Led experiments to determine binding time of blocking proteins on QCM and reduced blocking time from 60 minutes to just 15 minutes-Performed effective Data processing and Results Analysis using Excel

Ms, Biomedical Engineering

Bachelor Of Technology, Instrumentation & Control Engineering