May Breitbach

Background

About May Breitbach

As a continual learner, with an interest in health, I had little familiarity with medical device research, and then.I was offered an amazing opportunity to join the initial team at a start-up pre-clinical research organization, launching a 15+ year career in medical device and pharmacological research. My initiative, complete ownership of everything I do, and drive to go the extra mile for my team and customers made me an invaluable asset. Being a key contributing member to the growth of that company and my team members was a transformative journey, with challenges and triumphs that drove my personal and professional development. Working alongside professionals from diverse backgrounds, I became a SME and gained valuable lessons and comprehensive experience across diverse franchises, such as wound healing, interventional cardiology, neurology, and embolization, that I carried with me to new leadership opportunities where I further developed my technical, scientific, and medical writing skills. In my last 3 years at NAMSA, I gained knowledge & skills in assessing biological and toxicological risk in accordance with global regulatory requirements. I also have additional experience supporting FDA inspections-front & back rooms. Expertise: • Pre-Clinical Operations • Regulatory Compliance • Project Management • Process Improvement • Team Leadership & Mentorship • Written & Oral Communication • Cross-functional Collaboration • Analytical Problem Resolution • Research & Analysis • Quality Assurance • Customer Service • Policies & Procedures Attributes: • High character • Adaptable (flexible & resilient) • Self-directed & self-train • Analytical & critical thinker • Troubleshooting & problem-solving; go beyond fixing, identify root causes, find optimal solutions • Exceptional attention to detail • Aptitude for anticipating needs, foreseeing potential issues, & ability to assess impact across diverse cross-functional teams and multiple programs • Aptitude for customer service, driven to help others succeed • Commitment to quality; focus on continuous improvement, efficiency, consistency, & continuity Experienced in understanding of appropriate global medical device regulations, requirements, standards, and principles: FDA 21 CFR Parts 11, 58, ISO 13485, ISO 14971, ISO 10993, European Medical Device Regulation (MDR) 2017/745, Good Laboratory Practices (GLP), USDA, IACUC, ALCOA-C, HIPPA, SOP, AE, NCR, CAPA. Familiarity with 21 CFR Parts 803, 806, 820, ISO 20416, ICH, ECHA, REACH, OECD Principles of Good Laboratory Practices, and Japanese MHLW.