Jennifer Coble
Regulatory Policy Analyst - U.S. Food and Drug Administration - Center for Devices and Radiological Health (CDRH)
- Role
- Regulatory Policy Analyst at FDA
- Location
- Raleigh-Durham-Chapel Hill, NC, US
- LinkedIn followers
- 500 followers
About Jennifer Coble
Experienced Quality Professional / Seasoned Manager / In-Depth GXP Industry Knowledge • Highly Skilled Quality and Regulatory Professional with over 23 years of experience in FDA regulated industry. Deep understanding of regulatory requirements and standards, including FDA GxP regulations and ISO 13485 • Industry Expert in the areas of computer system validation, quality management systems, electronic document management systems, risk management and change control • Organized and Detail-Oriented Project Manager with ability to prepare and execute multiple initiatives simultaneously, delivering high quality results on time • Collaborative Team Player able to take the lead while promoting group cohesion, demonstrated success in working on global teams across multiple languages and time zones to meet business priorities • Demonstrated success in driving change during company integrations and supporting global acquisitions • Excellent soft skills including leadership, communication and problem-solving abilities, mentoring and talent development • Global manager experienced in leading co-located diverse teams crossing time and language barriers to complete objectives Areas of Expertise • FDA GxP Regulations • ISO 13485 • Medical Device 510k • Risk Management • Change Control • Internal/External Quality Auditing • Quality Systems Development • Project Management • Replacing paper-based process with validated systems • Mentoring/Talent Development
Experience
Regulatory Policy Analyst
Sep 2023 — Present
Education
Wake Technical Community College
AAS, Medical Laboratory Technology
1992 — 1994
Western Carolina University
Master of Project Management, Project Management
2018 — 2020
North Carolina Wesleyan College
BS, Computer Information Systems
1996 — 1999
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