Lori Holder
Medical Device Regulatory Affairs Leader | Global Medical Device Regulatory Strategy | FDA PMA/510(k)/De Novo | Ophthalmic & Implantable Devices
- Role
- VP, Regulatory Affairs at Opzira, Inc
- Location
- Dallas-Fort Worth, TX, US
- LinkedIn followers
- 500 followers
About Lori Holder
Global Regulatory Affairs executive with 30+ years of experience leading regulatory strategy, regulatory operations, and quality systems for medical device companies ranging from emerging innovators to global industry leaders. My background spans ophthalmic, cardiovascular, neurological, and orthopedic technologies, including Class implantable products. I have built and led global regulatory organizations, secured complex approvals (including U.S. De Novo authorization), served as EU PRRC, and guided companies through EU MDR transitions, acquisitions, and corporate separations. My expertise includes FDA PMA/510(k)/IDE submissions, EU MDR/IVDR compliance, ISO 13485 and QMSR alignment, global registrations, lifecycle management, regulatory operations, and digital regulatory transformation. Known for aligning regulatory strategy with business goals, I partner with executive leadership, R&D, clinical, quality, and commercial teams to accelerate innovation while ensuring compliance and market access worldwide. I enjoy mentoring regulatory professionals and advising companies on building scalable, high‑impact regulatory organizations.
Experience
VP, Regulatory Affairs
Sep 2025 — Present
Education
Texas A&M University
BS, Bioengineering
1986 — 1990
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