Open to opportunities

Eric Llewelyn

@ericllewelyn

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Senior leader in Quality Assurance & Regulatory Affairs.

United States

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What I'm looking for

I seek a role that fosters collaboration, innovation, and continuous improvement in quality assurance and regulatory affairs.

I am a transformative and detail-oriented leader with extensive experience in Quality Assurance and Regulatory Affairs. My career has been marked by a proven ability to champion diverse initiatives and drive organizational workflows to achieve established goals. I excel in developing and executing strategic business plans, cultivating sustainable relationships with cross-functional teams, and maintaining oversight of quality management systems for medical devices.

Throughout my career, I have held senior leadership roles, including Senior Director of Quality Assurance & Regulatory Affairs at Dunamis Medical, where I ensured compliance with regulatory agencies such as the FDA and ISO standards. My expertise in risk management and quality assurance has allowed me to redesign quality management systems and lead successful regulatory strategies for product approvals. I am passionate about mentoring teams and fostering collaboration to enhance operational efficiency and compliance.

Experience

Work history, roles, and key accomplishments

Current

Senior Director of Quality Assurance & Regulatory Affairs

Current

Dunamis Medical

Jan 2023 - Present (2 years 5 months)

Served as Senior Quality Management Representative, maintaining oversight of Class 2 medical devices and testing laboratories including microbiological, hardware, and packaging. Redesigned the company’s Quality Management System to comply with 21 CFR Part 820, ISO 9001/13485 and ensured audit compliance with regulatory agencies like FDA, OSHA, EPA. Developed regulatory strategies to secure product

Quality Management Systems Regulatory Affairs FDA ISO 13485 ISO 9001 21 CFR 820 510(K)CE Marking CAPA Internal Audit

Chief Compliance Officer, Quality Assurance & Regulatory Affairs

Algorithmic Intuition

Jan 2021 - Dec 2023 (2 years 11 months)

Served as Senior Quality Management Representative, maintaining oversight of FDA product market clearance and testing laboratories for AI/ML medical devices. Achieved compliance with ISO 90001/13485 and FDA 21 CFR Part 820/11 by establishing the company's Quality System. Championed efforts across clinical research studies for Class 2 and 3 devices and ensured compliance with various regulatory age

FDA ISO 13485 21 CFR 820 Clinical Research Quality Management Systems

Vice President, Quality Assurance & Regulatory Affairs

AlphaProTech, Inc.

Jan 2010 - Dec 2021 (11 years 11 months)

Maintained complete oversight of quality and regulatory aspects for three domestic and five foreign contract facilities, serving as Senior Quality Management Representative. Drove alignment with regulatory agencies including FDA, Health Canada, and CDC, and developed annual domestic and international regulatory and quality assurance strategies. Played a pivotal role in developing and instituting t

FDA ISO 9001 ISO 13485 Regulatory Strategy Quality Management Systems Team Leadership