Genevieve Flynn

• Manage regulatory change required by new and revised laws and regulations, communicating complex requirements and identifying operational impacts.
• Prepared, submitted, and provided feedback on CE Technical files in compliance with IVDD and IVDR to regulatory agencies. Development of strategies for successful interactions with regulatory agencies to ensure timely review and approval of submissions.
• Involved in registration activities for new product launches and renewal of existing licenses.
• Control the distribution of product from a regulatory perspective through the regulatory stop-ship program.
• Manage Field Actions process as required.
• Complete the review and approval of product labeling and device modification proposals to ensure compliance with applicable regulations and guidelines.
• RA representative on Innovation Design Projects and Design Change Projects.
• Support the preparation and submission of 510k for US clearance, as required.
• Participate in QSMR, internal, and external site audit activities for RA.

RA

• Prepared and maintained CE Technical files in compliance with IVDR and IVDD.
• Developed and maintained registration strategies for new product launches.
• Controlled the distribution of product from a regulatory perspective through the regulatory Stop Ship program.
• Support preparation and submission of 510k for US clearance, as required.
• Manage FA process and review, approval of product labeling, and device modifications.
• Support global RA tasks/projects as required.
• Representative on IDP and Design Change projects.

QS

• Coordinate the internal audit program for BCII, prepare the schedule, and work with auditors to ensure availability and completion of internal audits.
• Subject matter expert for internal audit program.
• Mentor/train colleagues and/or site on QS-related topics.
• Provide site support on Quality System issues to ensure adherence to applicable quality-related standards, regulations, and internal procedural requirements.

• Mentor/train colleagues and/or site on QS related topics
• Prepare and participate in external third-party audits at BCII (FDA, NSAI, BSI etc.)
• Support the implementation of timely CAPA process
• Assist in Quality System Management Review (QSMR) presentations
• Participated in quality system simplification projects/kaizens
• Maintain the quality system documentation system
• Complete any other tasks requested by the Quality Systems Manager BCII, and act as delegate in his/her absence.