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Lisa Whitman

@lisawhitman861

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I lead medical device quality systems, regulatory compliance, audits, and CAPA programs.

United States

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What I'm looking for

I'm seeking a challenging Quality Assurance and/or Regulatory Affairs position with a medical device manufacturer, where I can lead quality systems, regulatory compliance, audits, and continuous improvement.

I've led RA/QA at Precision Medical, managing Quality Control and Repairs teams while maintaining FDA establishment registrations, device listings, Health Canada licenses, international licensing, and Certificates of Foreign Government.

I handle complaint investigations, recall coordination, Management Review, external MDSAP/ISO 13485 and customer audits, internal audit oversight, CAPAs, QMS validation, design controls, risk management, change control, UDI, labeling, and Device History Records.

Previously, I managed FDA Letters of Authorization and regulatory data migration at West Pharmaceutical Services, and built experience in document control, supplier quality agreements, GUDID submissions, UDI, audits, SOPs, and compliance projects at Medical Components.

Experience

Work history, roles, and key accomplishments

Director RA/QA

Precision Medical, Inc.

Jan 2023 - Jun 2026 (3 years 5 months)

Managed diverse team encompassing Quality Control and Repairs teams. Prepared and maintained FDA registrations, Health Canada licenses, and international regulatory filings; investigated complaints and evaluated reportability; served as Recall Coordinator and conducted management reviews.

FDA Regulations Health Canada Regulations ISO 13485 MDSAP CAPA Design Control Risk Management UDI QMS Internal Audit Supplier Audits Labeling Change Control Complaint Investigation Recall Management UL Standards

Regulatory Specialist

West Pharmaceutical Services

Jun 2021 - Jan 2023 (1 year 7 months)

Managed Letters of Authorization (LOAs) to the FDA for customer drug applications. Interfaced with pharmaceutical customers to ensure timely and accurate LOA execution and managed regulatory data migration to MasterControl.

Regulatory Affairs FDA Submissions MasterControl Data Migration Labeling Client Communication

RA/QA Assistant Manager

Precision Medical, Inc.

Aug 2020 - May 2021 (9 months)

Qualified international distributors and maintained relationships with them. Evaluated change control orders for significant changes and impact to QMS; performed internal audits for MDSAP conformity and authored audit reports.

MDSAP Internal Audit CAPA Change Control QMS Supplier Qualification

Compliance Associate

Medical Components, Inc.

Jul 2018 - Aug 2020 (2 years 1 month)

Authored and edited SOPs within BSI's Entropy Document Management System and negotiated Supplier Quality Agreements. Managed UDI submissions to GUDID and prepared for EU UDI requirements of MDR.

Technical Writer Document Control UDI GUDID Nomenclature Technical Quality Agreements Internal Audit Regulatory Compliance Budget Management

Change Control Admin

Medical Components, Inc.

Nov 2016 - Jul 2018 (1 year 8 months)

Coordinated with Engineering, Regulatory, Operations, and Quality on behalf of Product Management to fully document product and labeling changes. Reviewed and redlined product Bills of Material, labels, and process documents.

Change Control Document Control Product Lifecycle Management Cross functional Coordination