Open to opportunities

Shelly Gallup

@shellygallup

I lead global medical device regulatory and quality strategies that accelerate approvals, inspections, and market access.

United States

Message

What I'm looking for

I'm seeking a senior regulatory and quality leadership role where I can build inspection-ready teams, modernize QMS operations, accelerate global market access, and align compliance strategy with business growth and patient outcomes.

At Glidewell Dental, I lead Regulatory Affairs and Quality Assurance for a global dental device manufacturer, rebuilding a 60-person US and Costa Rica team while directing FDA submissions, international registrations, MDSAP, and ISO 13485 audits.

Across Innova Medical Group, Sekisui Diagnostics, and Prismatik DentalCraft, I've closed FDA Warning Letters and 483s, secured 510(k), CLIA, ANVISA, GMP, and global registrations, and built regulatory teams for IVD, point-of-care diagnostics, and medical devices. I modernize quality systems, including ETQ modules, to improve inspection readiness, compliance control, and review speed.

I've spent more than 20 years aligning regulatory excellence with business objectives across Class I, II, and III devices, combination products, and international markets.

Experience

Work history, roles, and key accomplishments

Current

Senior Vice President of Regulatory Affairs and Quality Assurance

Current

Glidewell Dental

Jan 2022 - Present (4 years 8 months)

Recruited back to global dental device manufacturer to revitalize underperforming RA/QA operations, rebuild trust across departments, and elevate regulatory strategy. Reorganized and strengthened a 60-person RA/QA team across the US and Costa Rica, and modernized quality infrastructure by implementing ETQ modules.

Regulatory Affairs Quality Assurance MDSAP ISO 13485 CAPA Change Control Team Leadership Budget Management