Medical Device Expert: In-Vitro Diagnostics, ISP, CFR,

Technical Consultant #1902


Expertise

  • 510k submissions in medical devices.
  • New business and PMP skills managing multiple international projects.
  • Technical proficiencies and strategic planning to optimize existing products and develop new IVD assays.
  • Risk management: Providing risk management assessments, FMEA - design and process, and developing risk management protocols.
  • Composing and documenting product requirements specific to FDA, CLSI, ISO and CE regulations.
  • Technology transfer.
  • Regulatory activities: Quality Control (QC) and analysis, FDA applicants, process, controls and labeling.
  • IVP (Intravenous Pyelogram) blood clotting essays, coagulation, and freeze drying.

Experience

Undisclosed Company, Independent Consultant, 2011 - Present

  • Utilize competencies in strategic planning, analysis, report writing and technical expertise to facilitate my clients' 510k submissions for medical devices.
  • Vendor management on three occasions for World Health Organization testing laboratories (1 International), INR assignment and statistical analysis.
  • Reports and communications: Communicate project information to multiple contractors and provide regular reports to VP's and project teams.
  • Risk management: Generate risk management protocol, risk assessment, design and process FMEA.
  • Design development planning: Write product requirements document and requirements traceability matrix while integrating regulatory guidelines from FDA, CLSI, ISO, and CE.
  • Design verification planning: Create equipment validation plan, performance qualification protocols, stability plan and stability protocols.

DSRV Inc., (STAGO), Atlanta, GA, Program Manager, 2009 - 2011

  • Executing new business and PMP skills to manage multiple international projects charged with responsibility of being the face of the company with both our international customers and global internal departments.
  • International technology transfer: Responsible for the transfer of a 510(k) medical device from the U.S. facility to the client site in Germany (Siemens); strategic master plan, risk management plan, quality plan, procurement plan, monitoring and control of activities at DSRV and client site, statistical analysis and final report. Project successfully completed on schedule in 12 months.
  • Business development strategy: Created the feasibility study and project charter for FDA "de novo" ELISA Collagen Binding Assay. Secured clinical testing sites and collaboration with leading experts in the field. Estimated sales U.S. $4.5 million.
  • Relationship development and team building: Utilized interpersonal and leadership skills to establish new relationships between various functional groups within our parent company in France and U.S. group. This led to the creation of a cross-functional project team between the two sites and the creation of several new projects (INR calibrators and ready to use assays) generating new revenues expected to reach U.S., $5 million in 3 years.

Octapharma Plasma, Atlanta, GA, Senior Project Manager, 2006 - 2009

  • With strong leadership, multi-disciplinary skill sets and organizational skills, successfully managed the relocation of the Australian manufacturing facility to Atlanta, U.S.
  • This required extensive planning, co-ordination and communication to ensure international customers maintained adequate stock of diagnostic reagents during the transition.
  • Project management: Manage cross-functional teams in both Australia and U.S, coordinate and monitor activities/schedule for manufacturing and quality control departments, logistics, and human resource plan, hire staff and manage the contractor selection process.
  • Manufacturing: Write and monitor the execution of inventory management plan, risk management plan, environmental testing plan, equipment validation plan, product validation plan, and stability protocol.
  • The U.S. manufacturing facility was granted FDA establishment.
  • Realized subsequent revenues from operations U.S., $3 million.

Life Therapeutics, Sydney, Australia, Project Manager and Product Development, 2003 - 2006

  • Through technical proficiencies and strategic planning optimized existing products and develop new IVD assays.
  • Project management: Devised, monitored and executed a strategic plan to replace a critical raw material as part of a medical device worth 85% of the total division revenue (U.S., $2.5 million).
  • This included managing three clinical testing sites, statistical analysis, final validation report and collaboration with major customers.
  • Co-wrote FDA 510(k) application for a Factor V Leiden assay. Revenues of over $1 million in the U.S.
  • Product development of INR calibrators; responsible for developing the manufacturing/QC processes, optimizing lyophilisation cycles, establishing independent external test sites, determining product requirements, change control and risk analysis.

Honors & Publications

Credentials

  • Project Management Institute

Academic and Professional Affiliations

  • International Society for Thrombosis and Haemostasis - U.S.A.

Education

  • M.B.A . Leadership/Strategy, Georgia State University, Atlanta, GA
  • B.S Transfusion Science, University of the West of England, Bristol, United Kingdom
  • B.S. Human Anatomy and Biology, University of Liverpool, Liverpool, United Kingdom
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