Gina Rogers Email and Phone Number

Act as RA lead on multiple products that will be transitioning from the IVDD to IVDR CE Marking.Collaborate with cross-functional groups (e.g., Quality Assurance, Research & Development, Marketing) to collect and coordinate information and regulatory documentation to assemble IVDR compliant technical files.Assist in the generation of Change Requests for product labeling according to Labeling conversion plan.Update IVDR Tracking Log, assure all documentation is prepared and processed timely to ensure KPIs and compliance schedule.Communicate and assist in the notification process to all International Regional Regulatory Affairs.Notification, logging of regional responses and tracking RA Regional activities to completion.Ensure product restrictions are implemented, as required Perform other IVDR or regulatory related duties as required or assigned.

Successful completion of Class I, Ir, II Technical Files for EU MDR and IVDR submissions to BSI within the required target dates per corporate EU MDR compliance initiative.Acted as RA Lead for New Product Development Team for several Class II Electromechanical EU MDR/IVDR CE Mark Submissions.Created robust global regulatory strategies and ensure product changes are reviewed and effectively communicated to global partners.

As Director of RA/QA, led activities related to the tracking, compilation, publishing, review, and archiving of regulatory submissions to health authorities worldwide for Qlarity a division of Paragon, providing support to their AI digital health portfolio. Ensured conformance with regulatory requirements, guidelines, internal standards and timelines. Maintain an efficient and effective Quality Management System. Provided expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance. Prepared regulatory submissions in support of assigned projects including but not limited to 510Ks, and related communication with FDA.Developed and managed internal audits on products, complaints, and related internal quality system improvement projects.

Provided leadership and quality-oriented focus to identify, plan and implement the policies and procedures within the business.Ensured compliance with medical device regulatory standards, FDA Quality System Regulation (QSR), ISO 13485:2016 and equivalent-international regulations through the development process and ongoing quality/regulatory compliance in manufacturing.

Management Representative to the FDA and Competent Authorities. Responsible for company compliance activities related to Regulatory Filings, US FDA, ISO, Canadian Medical Device, EU MDD/MDR and other global regulatory requirements. Organized, planned and directed Regulatory Affairs strategy and Quality Management System.Developed compliant policies, procedures, and training to ensure efficient and effective operation of the quality system and regulatory requirements for CE Mark/ISO 13485/FDA QSR.

Led cross-functional team meetings to determine appropriate actions to execute product recalls.Analyzed documentation for ensuring GMP/GDP, overall compliance and domestic regulatory reporting. Evaluated appropriate regulatory requirements to provide regulatory consultation to internal departments. Determined actions necessary to meet the Part 806 requirements.Established, evaluated and maintained recall documentation and historical record for recall projects and updated project status. Ensured closure of open Field Correction / Recall activities by liaising with quality/ service personnel to in accordance with FDA, Health Canada and customer commitments.

Performed on-site internal auditing of Pfizer’s Michigan Laboratories, including Ann Arbor and Kalamazoo, to ensure DEA Compliance in accordance with the Controlled Substances ActPerformed validation and qualification activities according to the approved validation protocols.Developed validation reports after execution activities were completed. Documented any deviations. Audited over 200 third party suppliers and service providers to ensure compliance to GMP and ISO 9001:2008.Created access database to manage and track qualified suppliers, maintain audit findings and reports, issue CAPA’s, automate audit schedule and support purchasing controls in conjunction with Procurement department.