Tamara Mccaw Email & Phone Number

Ottawa, ON, CA

Beaconsfield, Quebec, Canada

Custom regulatory consulting services for in vitro diagnostic and medical device companies. TAGA Consulting specializes in early strategic planning that unites Regulatory, Clinical, Quality, and Commercial concerns, and helps clients achieve success by: developing effective regulatory roadmaps and clarifying requirements; designing clinical studies that.

Toronto, Ontario, Canada

• Directed Regulatory, Clinical, and Assay Development activities that achieved Health Canada authorization of RALI-Dx IL-6 Severity Triage Test for COVID-19 assessment.
• Led cross-functional audit team through ISO 13485 / MDSAP extension audit with no non-conformances.
• Oversaw Quality Management System (QMS) process improvement projects for complaint handling, non-conformances, and corrective and preventive action (CAPA) to integrate risk management and ensure compliance with ISO.
• Developed regulatory strategy for novel, multiplexed IVD test for cytokines in lungs undergoing ex-vivo perfusion prior to transplantation.

Ottawa, Canada Area

• Key Clinical Affairs contributor to US Department of Defense proposal to develop a novel, point of care IVD product for traumatic brain injury (TBI) on the i-STAT System. Abbott was awarded the $35 million contract.
• Developed a phased approach to the TBI pre-market regulatory submissions and clinical studies, reducing the time to market for the first TBI product by 2 years. Achieved plan buy-in from US FDA and US DoD.

Ottawa, Canada Area

• Primary author of 510(k) for hematocrit test (K163342), Special 510(k) for potassium test, and technical file for CE Marking of new i-STAT Alinity IVD test system (13 tests).
• Negotiated regulatory strategy via Q-submissions and in-person meetings with FDA.

Ottawa, Canada Area

• Pioneered a new role within Abbott Point of Care, taking responsibility for clinical and regulatory strategy, cross-divisional execution of near-patient IVD clinical studies, and compliance with GCP and 21 CFR 812.

Ottawa, Canada Area

• Directed feasibility assessment for Thyroid Stimulating Hormone immunoassay: identified technical challenges, employed statistical techniques to drive to solutions, and demonstrated assay feasibility on time.

Ottawa, Canada Area

• Led execution of US Clinical Laboratory Improvement Amendments (CLIA) Waiver studies for brain natriuretic peptide (BNP) test and prothrombin time (PT) test. Authored regulatory submissions.

Ottawa, Canada Area

Senior Engineer, R&DSenior Engineer, Cartridge Assembly (Manufacturing)Senior Engineer, Sensor Fabrication (Manufacturing)Intermediate Engineer, Sensor Fabrication (Manufacturing)

Meng, Chemical Engineering

Bsc, Chemical Engineering