Open to opportunities

Kurtis Montegna

@kurtismontegna

Quality, Regulatory & Clinical Affairs executive at Danaher | Beckman Coulter Diagnostics, leading global teams and worldwide commercialization.

United States

Message

What I'm looking for

Global quality and regulatory affairs executive with 15+ years leading Quality, Regulatory, and Clinical Affairs organizations

At Danaher | Beckman Coulter Diagnostics, I lead integrated Quality, Regulatory, and Clinical organizations supporting worldwide commercialization of a $600M microbiology portfolio. My work includes FDA 510(k) strategy, software and cybersecurity submissions, and oversight across four manufacturing sites.

At Philips, I led a 275-person Regulatory and Clinical organization supporting a portfolio exceeding $5B. I reduced regulatory approval timelines by 219 days, improved FDA on-time delivery by 45%, and reduced CAPA cycle time by 248 days while improving CAPA effectiveness by 65%.

Across my career, I’ve built and transformed global Quality, Regulatory, and Clinical organizations. At Oricare / Aeonmed, I supported device commercialization in 143 countries; at VisionCare Devices, I obtained FDA 510(k) clearance K120170 and developed and installed an ISO 13485 QMS.

Experience

Work history, roles, and key accomplishments

Current

Senior Director, Global Quality, Regulatory & Clinical Affairs

Current

Danaher | Beckman Coulter Diagnostics

Jan 2024 - Present (2 years 8 months)

Executive leader for a $600M microbiology portfolio supporting worldwide commercialization. Lead integrated Quality, Regulatory, and Clinical organizations of ~200 professionals with 17 direct reports.

Quality Management Regulatory Affairs Clinical Affairs Supplier Quality Manufacturing Quality Design Assurance CAPA Complaint Handling Post Market Surveillance 510(K)Software Cybersecurity

Senior Vice President, Quality & Regulatory Affairs

Accelerate Diagnostics

Jan 2022 - Jan 2024 (2 years)

Executive leader responsible for global Quality, Regulatory, and Clinical transformation. Led FDA remediation of adulterated products resulting in Warning Letter avoidance.

Quality Management Regulatory Affairs FDA Remediation Warning Letter Avoidance Digital Quality Cybersecurity Software Governance Ab Initio 510(K)

Head of Regulatory Affairs & Integration / Head of Regulatory & Clinical Affairs

Philips

Mar 2017 - Jan 2022 (4 years 10 months)

Executive leader for one of Philips' largest global Regulatory and Clinical organizations, supporting a portfolio exceeding $5B. Led organization of 275 professionals with 19 direct reports.

Regulatory Affairs Clinical Affairs FDA CAPA Budget Management Manufacturing Integration Quality Management

Board Member (Fractional)

Oricare / Aeonmed

Jan 2017 - Jan 2022 (5 years)

Served as Board Member providing strategic guidance for global Quality, Regulatory, and Clinical organizations.

Board Governance Strategic guidance Quality Regulatory Clinical

Global Director

Oricare / Aeonmed

Mar 2013 - Mar 2017 (4 years)

Built global Quality, Regulatory, and Clinical organizations supporting worldwide expansion. Served as U.S. Agent and Management Representative.

Quality Management Regulatory Affairs Clinical Affairs MDR IVDR U.S. Agent Management Representative

Regulatory Affairs & Quality Assurance Manager/Director Sales & Marketing

VisionCare Devices

Feb 2009 - Mar 2013 (4 years 1 month)

Led Regulatory, Quality, and international commercialization for ophthalmic devices. Obtained FDA 510(k) clearance K120170 and developed ISO 13485 QMS.

Regulatory Affairs Quality Assurance ISO 13485 510(K)Cleanroom Design Product Commercialization