April Young, PhD

President and CEO

About

More than 15 years of Quality and Regulatory experience and expertise in medical device and pharmaceutical industries including leadership, compliance, audit, new product development, submissions, and working with Regulators. Strong communication, presentation, training, analytical, and problem-solving skills with proven project completion success and process improvement initiatives. Ability to form strong relationships, build strategic teams, and successfully work across global teams and with top management.

Country

United States

City

Minneapolis

Industry

Medical Device

Skill

Internal Audits, Life Sciences, Medical Devices, U.S. Food and Drug Administration (FDA), Regulatory Affairs, ISO 13485, Cross-functional Team Leadership, Pharmaceutical Industry, medical device, Quality System, regulatory , Regulatory Compliance, Auditing, Project Management Office (PMO)

Experience

President and CEO

Causeway Medtech, LLC

2023-9 - Present · 3 yrs 1 mo

Director Global Regulatory Affairs

Abbott

2022-6 - 2023-8 · 1 yr 3 mos

Director, Quality Compliance - Electrophysiology

Abbott

2021-4 - 2022-7 · 1 yr 4 mos

Director Quality & Regulatory Affairs

RxFunction, Inc.

2019-4 - 2021-4 · 2 yrs 1 mo

Greater Minneapolis-St. Paul Area

Regulatory Program Manager

Wright Medical

2017-9 - 2019-4 · 1 yr 8 mos

Quality Program Manager

Wright Medical

2015-11 - 2017-9 · 1 yr 11 mos

Consumer Safety Officer, Drug Specialist

FDA

2010-6 - 2015-11 · 5 yrs 6 mos

Greater Minneapolis-St. Paul Area

Independently perform audits and inspections at a highly technical complex level for compliance with Federal laws and regulations. Serve as subject matter expert in the area of pharmaceutical quality inspections. Manage Drug program areas including Drug Preapproval program, field alert monitoring, and drug quality reporting. Prepare inspectional reports documenting evidence as well as official recommendations pertaining to Preapproval inspections.