Responsible for ensuring compliance with FDA tissue regulations, ISO Quality System Standards and AATB Standards for Tissue Banking for BioStem tissue activities, including distributor training, auditing of distributor sites, standard operating procedures for tissue distributors, and compliance relationships with tissue bank
suppliers in support of BioStem business units.

Report to the Vice President, Quality and Regulatory Affairs. Engaged early in the product design and development phase through post-market with the objective to provide high-quality, reliable, and regulatory-compliant products to support worldwide market release in meeting the needs of clinical customers, patients, and Beckman business growth objectives.
• Lead and manage the Design Quality (Design Assurance) product functional group to realize the Development Quality mission of collaborating with product development, sustaining engineering, and other functional groups to efficiently bring regulatory-compliant new products to market that meet or exceed customer expectations.
• Business Unit Quality lead for the post-market quality, direct and in-direct to drive continuous improvement, best practice sharing, and harmonization.

Specialties: medical imaging; software development; cognitive neuroscience and neuropathology; systems integration; microscopy; stereology; big data. - Application of Software as a Medical Device (SaMD), (AI) Artificial Intelligence Lung nodule management.
• File maintenance and remediation
• MDSAP Quality Management System development, harmonization, and certification
• Regulatory submissions – 510K and CE

Support FMCNA's new medical device and marketed product development.
• Investigated and assessed changes to all existing products in compliance with applicable international and US federal laws.
• Provided leadership to regulatory professionals engaged in evaluation of changes.
• Collaborated with the Corporate Regulatory Affairs team to develop device-related regulatory submissions as needed.
• Formulated regulatory policies /programs.

Assisted medical device, pharmaceutical, and biotechnology manufacturers achieve compliance with global regulations while improving business processes, thus reducing both cost and risk. Teamed with Life Sciences industry experts and former FDA professionals to ensure that Regulatory and Quality systems were optimized for compliance and effectiveness. Helped organizations develop in-house expertise with our full range of Life Sciences RA/QA training courses. Key customers and products included Sanofi / Kaleo Pharma / Eli Lilly (combination product – drug delivery / Auto Injector – Auvi-Q), Stryker Instrument (device accessories - endoscopy), Hologic (control console for their breast biopsy system) and Cook Medical. Projects includes:
• Served as an intermediate between the FDA and the client to maintain and foster communication.
• Assumed interim staff position for provider of contract manufacturing and related services to specification developers of finished medical devices or medica

Regulatory Compliance Program Developer / Consultant Served a sterilizer and dental X-ray equipment manufacturer as a Regulatory Compliance Program Developer / Consultant.
• Completed business process re-engineering, CAPA, RG (Returned Goods), Post Market Surveillance, Investigations and Complaints.

• Quality System work stream – Production and Process Controls Project and Program Management.

Supervised direct and indirect staff of over 80 personnel. (Metrology / Calibration, Operational Quality –across three shifts, New Product Development– Product Development, Regulatory Affairs internal auditors, Clinical Management, Regulatory Submissions, and Supplier Quality.
• Clinical Affairs / Regulatory Affairs / Quality Assurance: Administered Day to day programs of a 420MM medical device manufacture. New product and distributor product support for Soft Tissue to bone fixation devices, knee and hip implantable products, biologics and pharma product development. Multisite responsibility for Ontario, CA – Fairlawn, NJ – Warsaw, IN and supply chain support.
• Strategic and Operational Quality experience (Clinical / QA / RA): 20+ years' experience in Quality Assurance, Compliance, Regulatory auditing and corrective action and Clinical coordination and study execution in a FDA regulated environment
• Clinical trial administration – (NAD) Needs Assessment Documentation / (IRB) Insti