Unifers.ai

Cheryl Bork

Senior Program Manager, Global Regulatory Affairs @Butterfly Network, Inc.

Wilmette, IL, US
EMAILS
[email protected]
MOBILE NUMBERS
+91 *********19

Signup · Get unlimited contacts

WORK HISTORY

Sep 2023 — Present

Senior Program Manager, Global Regulatory Affairs @Butterfly Network, Inc.

View department →

Provides global Regulatory Affairs leadership on new and modified product development projects and providing regulatory guidance to cross-functional product development teams. Provides regulatory strategic input and planning to product lifecycle planning and lead regulatory activities needed to obtain and maintain regulatory clearances/approvals. Oversee advertising and promotion, labeling, and restricted substances (e.g, REACH, RoHS). Negotiate and interact with regulatory authorities during the development and review process to ensure submission clearance/approval. Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams. Provide regulatory input on cybersecurity and Artificial Intelligence (AI).

EDUCATION

N/A

Colorado State University

Bachelor of Science, Majors in Biochemistry & Biology. Minor in Chemistry

N/A

University of Phoenix

MBA, Masters of Business Administration

N/A

University of Nebraska-Lincoln

BS, Biology

SKILLS

PmaCe Mark Change NotificationsMedical DevicesProcess ImprovementBiotechnologyProduct LaunchNotified Body AuditsGmpMedical SoftwareQuality SystemSoftwareChange Control510kMedical Device SoftwareStandard Operating Procedure (Sop)Six SigmaClinicalRegulatory SubmissionsU.s. Food and Drug Administration (Fda)U.s. Title 21 Cfr Part 11 RegulationResearch and Development (R&D)ValidationSopDesign ControlBusiness Process ImprovementClinical TrialsCe MarkingHealthcare ITIso 13485Fda Master FileClinical ResearchCorrective and Preventive Action (Capa)Pharmaceutical IndustryQuality AssuranceCapaNdaFdaV&VVerification and Validation (V&V)R&D

This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.