GINA MAIOLO
Avon,New York
Summary
Results-driven Regulatory Affairs Manager with a proven track record in regulatory strategy, submission management, and compliance auditing. Expertise in negotiating with regulatory bodies to facilitate successful product approvals.
Overview
22
22
years of professional experience
Work History
Sr. Regulatory Affairs Manager
Carestream Health Inc
Rochester, New York
05.2015 - Current
- Develop regulatory strategies for product submissions for various devices including digital radiography systems, mobile fluoroscopy, ultrasound, SaMD, AI technology
- Interact with FDA, lead Q-Subs, Submission Issue Requests (SIR).
- Support audits and inspections to ensure compliance with regulatory standards.
- Submitt applications and amendments to regulatory agencies worldwide.
- Negotiate filings and changes with regulatory bodies to facilitate approvals.
Regulatory Affairs Manager
Carestream Health Inc.
Rochester, New York
05.2014 - 03.2018
- Developed regulatory strategies for pharmaceutical dental anesthetics products such Lidocaine, Marcaine, Zorcaine.
- Implemented a Post Market Surveillance (PMS) system in accordance to EU MDR 2017/745.
- Implemented a fully automated eMDR reporting program from legacy paper-based reporting system
- Managed medical device reporting and global field actions and recalls
- Facilitated comprehensive training for ISO 14971
- SME for post-market surveillance and post-market regulatory during FDA and Notified Body audits
Technical Specialist
Baxter International Inc
Medina, New York
01.2011 - 12.2013
- Consultant-led mentorship gaining hands-on experience in specialized areas such as Regulatory (21 CFR) and QMS (21 CFR 820).
- Created device IFUs for Smart Pump Infusion System and accompanying IV sets.
- Designed customer portal to support Biomedical/IT staff and Baxter Technical Support.
- Assisted with medical device recalls.
Software Engineer
Eastman Kodak
Rochester, New York
03.2004 - 11.2012
- Developed KODAK Professional Digital Print Production software (DP2) to optimize professional photo labs with image output, image enhancements, and automated workflows.
- Provided on-site support for labs transitioning from analog to digital.
- Collaborated with cross-functional teams on project requirements and design specifications.
- Developed, tested, debugged and documented software programs using C++, Java, JavaScript and HTML
Education
MBA - Executive MBA
Rochester Institute of Technology
Rochester, New York, NY09-2016
Bachelor of Science - Information Technology
Statue University of New York
Utica, NY06-1998
Skills
- Regulatory strategy
- Submission management
- Compliance auditing
- Quality assurance
- Data analysis
- Risk management
- Policy negotiation
- Product registration
- Risk assessment
- Team building
- Problem solving
- Clinical trials protocols
- Technical writing
- Pharmaceutical industry
- Biotechnology industry
- 21 CFR
- Regulatory agency applications
- FDA interactions
- Post-market surveillance
- Recall management
Affiliations
- Reading and Writing Volunteer - Anna Murray Douglas Academy
- Habitat for Humanity
Timeline
Sr. Regulatory Affairs Manager
Carestream Health Inc
05.2015 - Current
Regulatory Affairs Manager
Carestream Health Inc.
05.2014 - 03.2018
Technical Specialist
Baxter International Inc
01.2011 - 12.2013
Software Engineer
Eastman Kodak
03.2004 - 11.2012
MBA - Executive MBA
Rochester Institute of Technology
Bachelor of Science - Information Technology
Statue University of New York