https://www.brosseauconsulting.comMedical Device and Biologics Professional With Varied and Extensive Experience in Regulatory Submissions, Quality System Management, and Executive ManagementAchievement of marketing and clinical trial approvals for various medical devices and tissue-based implants. Successful regulatory approvals in domestic and international markets for devices of varied classifications and across numerous therapy areas. Expertise of the Quality System Regulation, EU Medical Device Regulation, MDSAP audit program, international QMS requirements, and medical device quality standards including FDA Recognized Consensus Standards and EU Harmonized Standards for medical devices. Two decades of implementing, operating, and improving Quality Management Systems for medical devices and biologics. Extensive experience in auditing (internal and supplier), corrective and preventive action, document and record control, design control, device master records and device history records, management review, material controls, non-conformance control and evaluation, post-market surveillance, purchasing and receiving controls, recalls, risk management, sterilization and cleaning, supplier management, training, verification and validation.Demonstrated success in representing various organizations in audits performed by the FDA, Notified Bodies, state regulatory agencies, and international regulatory agencies. Perform numerous mock regulatory audits for corporate audit preparedness. Prompt interpretation and resolution of FDA Warning Letters, Notified Body and Auditing Organization audit nonconformances, and general QMS compliance issues with thorough corrective action and rapid closeout. Management and mentoring of staff in various quality, regulatory, and technical roles and with varied backgrounds and education. Accomplish corporate goals for complex projects by managing resources, conducting strategic assessments, and ensuring stakeholder requirements are met.