Claire Jin

- Authored IVDR technical documentation templates (STED, GSPR, PEP/ PER, SSP, DoC, SVR, SLRP/ SLRR, APP/ APR, CPSP/ CPR, PMSP/ PSUR, and PMPF exempt justification) tailored for a multiplex antigen test - Worked on a 510(k) for a multiplex antigen test - Reviewed performance bench testing reports for a multiplex antigen test - Reviewed IFUs and ad promos - Authored a UDI SOP specific to software - Authoring a labeling and ad promo SOP

• IVDR o Updated Technical Documents (STED, GSPR, PEP, PER, DoC, and SSP) on a quarterly basis o Reviewed and provided feedback on cross-function documents for Post Market Surveillance (PMS), Clinical Performance, Scientific Validity, and various levels of device labels o Drove a change request for a sample preparation unit with an integrated computer o Authored Assessments for change request RA assessments to determine US, EU, and UDI registration implications o RA lead in IVDR Stability compliance project by interpreting and providing stability protocol and report requirements outlined in IVDR and ISO 23640 • Document Management System (DMS) o Supported Go Live of DMS for global regulatory premarket submission dossier (Technical Documents, 510(k)s, and global dossiers)  Created content plan for 9 STEDs  Uploaded Technical Documents into DMS per content plan o Maintained DMS content during the Technical Document quarterly updates • Document of External Origin and Regulatory Intelligence o BDB Regulatory Lead for Regulatory Intelligence and Document of External Origin (DEO)  Tracked BDB applicable regulations and guidance documents  Lead Regulation/ Guidance Assessment Review monthly meetings o Site Owner for DEO Management  Maintained and revised BD Biosciences (BDB) Standards List and Standard owners  Managed and took part in BDB standard gap assessments for applicable standards and guidance documents  Co-chaired quarterly BDB Standards committee meetings and records the meeting minutes  A conduit between Global Process Owner (GPO) and BDB standards committee  Communicated and updated information related to standards across corporate (BDX) and BDB • Led International RA and Quality Data Harmonization Project o Managed cross functional project team members in meeting key timelines

• Reviewed and Updated Technical Documents o Utilized documents and standards referenced in the STED, quality checked that the data in the STED, SSP, GSPR, and DoC is accurate o Updated the STED, SSP, GPSR, and DoC according to QC findings • Lead International Regulatory and Quality Data Harmonization Project o Managed cross functional project team members in meeting key timelines • Process Owner of Post Market Surveillance (PMS) Activities o Managed PMS documents schedule o Reviewed and completed Post Market Surveillance SOPs o Prepared PMS Plans, PMS Reports, and PSURs for products compliant with IVDR o Managed and obtained raw data for PRER required by China NMPA • Document of External Origin (DEO) Management o Maintained BDB List of applicable External Standards • Complaint Handling o Included all responsibilities when employed as a contractor (see below) o Co-lead process improvement projects  Legacy Blitz to close remaining EUMEA legacy complaints  Aging complaint project that decreased complaints that are over 180 days old o Identified and drove correction and alignment of Regulatory Status in Regulatory Information Management (RIM) system, SAP, ServiceMax, and Trackwise via a corrective action plan

• Complaint Handling o Responsible for life cycle of complaints o Processed and closed complaints in accordance with regulatory requirements and company procedures o Investigated Research Use Only Medical Device Reporting (MDR) complaints  Drove re-write of the Investigation Guidance o Co-lead the EU/ MEA Regional complaint team  Responsible for aligning goals of BDB and the region  Responsible for meeting metrics  Co-lead the biweekly meetings with the region  Point of Contact for complaints coming from the region • Assessed the Severity of Adverse Events for the 2021 WHO Annual Report • Redlined Complaint Processing Guidance document • Redlined Standard Operating Procedures pertaining to catalog numbers not subject to adverse event assessment and reporting

• Updated, designed, and populated Regulatory information management systems o Updated the database for products that are CE marked and related DoC o Designed and populated a spreadsheet to enable visualization of EU MDD to MDR submission schedules o Designed and populated a spreadsheet to capture SKUs registered in different countries o Consolidated multiple recall lists into a master list spreadsheet o Designed and populated a spreadsheet to capture information pertaining to the catalog numbers covered by each 510(k) for each business unit • Change control - tracked impacted country registrations • Inventoried and reorganized the 510(k) files • Analyzed and identified the top 5 concerns about obtaining renewals from Notified Bodies to improve renewal submissions proactively • Received training for CFGs, EU MDR, 510(k) submissions, and change controls