Open to opportunities

Timothy Cowart

@timothycowart

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Senior regulatory and quality specialist improving medical devices from design controls to global submissions.

United States

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What I'm looking for

I’m looking to improve existing commercial medical devices that lead to better patient care and provider decisions, and to bring innovative medical device technologies to the global marketplace to address public health needs.

I’m a medical device regulatory and quality leader who improves patient care by strengthening global submissions, documentation, and compliance. I bring a deep focus on “innovative, novel, and cutting-edge medical device technologies” to address public health issues and improve provider decisions and services.

Across my career, I’ve led quality and regulatory teams through audits and approvals that enabled commercial distribution—most notably moving Class III systems from pre-production to market. At Koning Corporation, I established and strengthened quality and regulatory functions and led cross-functional teams for PMA original submissions and supplements supporting software, hardware, and design changes.

In regulatory and data-integrated work, I’ve supported 510(k)’s and PMA supplements for mobile apps and cloud-based products, including fast/long-acting insulin pen injector hardware, firmware, SaMD, and analytics. As a regulatory SME, I’ve worked on AI algorithms for clinical decision support, including risk evaluations, usability assessments, and q-submissions—while representing regulatory teams during internal audits by FDA, GMED, and ECM.

I also share this expertise through teaching at Georgia Tech’s Biomedical Innovation and Development program, guiding graduate design teams on global regulatory assessments, design controls, human factors, clinical evaluations, and commercialization. My professional ethos is clear: build compliant systems that translate into safer, more effective medical outcomes for patients and providers.

Experience

Work history, roles, and key accomplishments

Current

Project Manager

Current

Koning Corporation

Oct 2025 - Present (8 months)

Led the ISO 13485 annual recertification audit and a successful MDSAP audit to secure certificate renewal. Prepared and submitted regulatory packages, including an FDA PMA Supplement for expanded clinical indication and Saudi SDFA registration, plus BDD submission work for expanded AI (SaMD).

ISO 13485 MDSAP PMA Supplements SaMD AI Regulatory Submissions Regulatory Strategy Quality Management Systems

Senior SME Specialist

Medtronic MiniMed

Mar 2021 - Dec 2025 (4 years 9 months)

Assimilated Companion Medical into Medtronic’s parent quality/documentation system and served as a regulatory SME for diabetes-management mobile apps and cloud products (including SaMD). Led regulatory packages and EU documentation updates for 510(k)/PMA supplement work, including Notified Body audit responses, AI algorithm human factors/risk submissions, and manufacturing site change approvals.

510(K)PMA Supplements SaMD AI Algorithms Human Factors Q Submission

Director Quality Assurance

Koning Corporation

Jun 2017 - Feb 2021 (3 years 8 months)

Directed and strengthened the quality and regulatory departments and led cross-functional teams to bring a Class III cone beam CT system from pre-production to commercial distribution. Authored a 180-day original PMA supported by clinical study data and multiple PMA supplements, and led manufacturing site change submissions and FDA-inspection readiness.

PMA Supplements Manufacturing Site Change Validations FDA Inspections Risk Management

Adjunct Professor

Georgia Institute of Technology

May 2016 - Dec 2019 (3 years 7 months)

Taught graduate biomedical innovation coursework and delivered lectures on global regulatory assessments and submissions, quality compliance, design controls, design testing, human factors/usability, and clinical evaluations. Mentored design teams through development and testing of medical device concepts from early planning through commercialization.

Global Regulatory Affairs Design Control Design Testing Human Factors Clinical Evaluation Quality & Compliance

Regulatory Contractor

DePuy Synthes

Mar 2016 - Jun 2017 (1 year 3 months)

Assessed design changes and supported submissions with design, quality, and regulatory teams for orthopedic device product lines, including 510(k) and Special 510(k) work. Supported MRI compatibility and labeling change assessments, guided test approach/datasets against FDA MRI guidance and ASTM standards, and participated as regulatory lead on multiple development and safety committees.

510(K)MRI Compatibility Regulatory ASTM PMA Real Time Review (RTR)Committee Regulatory Leadership

Senior Director Regulatory

St. Jude Medical

Jun 2014 - Feb 2016 (1 year 8 months)

Post-acquisition, assessed and prepared CardioMEMS documentation integration into St. Jude Medical systems and supported PMA Supplement submission for cardiac output software algorithm changes. Led regulatory manufacturing relocation V&V activities for the Reader and Antenna transfer and supported FDA-related regulatory inspections tied to the production move.

PMA Supplements Inspections Manufacturing Relocation Validation (V&V)Quality Management Systems Submission Level Assessment

Vice President Regulatory

CardioMEMS, Inc.

Oct 2008 - May 2014 (5 years 7 months)

Directed global FDA and EU regulatory and quality compliance programs for a novel implantable wireless sensor platform, including pulmonary artery and intracranial pressure monitoring. Led clinical and usability studies, including a 64-site HF clinical trial with 600+ patients, and achieved PMA approval and follow-on PMA Supplement approvals and modular submission development.

IDE Clinical Trial Oversight Usability Studies Global Regulatory Strategy Risk Management

Director Quality Assurance

Microsulis Medical Limited

Apr 2003 - May 2006 (3 years 1 month)

Led quality and regulatory compliance programs across FDA, MHRA, EU, Health Canada, and TGA requirements, including establishment and improvement of quality systems and design controls for Class II/III medical devices. Directed international FDA inspections and Notified Body audits and led development and submission of an original PMA for a Microwave Endometrial Ablation System with multiple PMA s

FDA Inspections PMA Submissions PMA Supplements 510(K)

Executive Director Quality

Healthdyne, Inc.

Jan 1981 - Dec 1999 (18 years 11 months)

Managed regulatory, quality, reliability, clinical, and quality control organizations across multiple business divisions and led teams through FDA facility/bioresearch inspections. Secured major regulatory outcomes including 12 IDE studies, 3 first-of-a-kind PMA approvals, 12 PMA supplements, and 64 premarket 510(k) clearances, and led software/firmware validation program implementations.

PMA Supplements 510(K)