Kathleen Di Leo
MILWAUKEE,WI
Summary
Accomplished Senior Regulatory Affairs Specialist at Cardinal Health with expertise in technical writing and regulatory compliance. Successfully authored PMA Annual Reports and 510(k) submissions, driving process improvements and enhancing audit readiness. Proven ability to collaborate cross-functionally and navigate complex medical device regulations, ensuring seamless product changes and compliance.
Overview
6
6
years of professional experience
Work History
Senior Regulatory Affairs Specialist
Cardinal Health
Remote, WI
11.2022 - Current
- Authored Regulatory submissions including PMA Annual Reports and 510(k)
- Identified opportunities for process improvements in regulatory affairs, and drove changes to completion.
- Provided regulatory guidance to cross-functional business and engineering teams regarding regulatory requirements for notification, submission, and compliant implementation of proposed changes to products and processes.
- Provided backroom and front-room support for a variety of audits, including MDSAP Surveillance Audits, FDA Manufacturing Facility Audits, and EU MDR Audits.
Regulatory Affairs Specialist
Cardinal Health
Remote, IL
07.2020 - 11.2022
- Maintained EU Technical Documentation to support extension of MDD CE Certification
- Handled Regulatory Assessments for product changes for Surgical Drapes, Gowns, Face Masks, and
Infection Control Apparel. - Monitored changes in legislation related to medical device regulation, labeling, and marketing claims.
Regulatory Affairs Specialist
Hollister Incorporated
Libertyville, IL
06.2019 - 07.2020
- Produced application dossiers and related documentation for international regulatory registrations and amendments.
- Organized and maintained all files related to regulatory actions.
Education
Bachelor of Science - Biomolecular Engineering
Milwaukee School of Engineering University
Milwaukee, WI05-2019
Skills
- Technical writing
- Labeling and packaging
- Process improvement
- Audit support
- Regulatory compliance
- Technical documentation
- Cross-functional collaboration
- Change management
- Medical device regulations
- FDA submissions
Timeline
Senior Regulatory Affairs Specialist
Cardinal Health
11.2022 - Current
Regulatory Affairs Specialist
Cardinal Health
07.2020 - 11.2022
Regulatory Affairs Specialist
Hollister Incorporated
06.2019 - 07.2020
Bachelor of Science - Biomolecular Engineering
Milwaukee School of Engineering University
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