Jon A.
AI & Cybersecurity | Driving Domestic/Global Strategy & Compliance | FDA/EU Submissions & Quality Systems | Process Innovator & Stakeholder Engagement Leader
- Role
- Lead Regulatory Affairs Specialist at GE HealthCare
- Location
- New York, NY, US
- LinkedIn followers
- 500 followers
About Jon A.
While navigating the intricate world of regulatory affairs, I\'ve carved a niche in orchestrating seamless FDA, and global submissions across the spectrum of medical devices, pharmaceutical drugs, and clinical research. With a rich foundation in life sciences and medtech innovation and a keen eye for the evolving regulatory landscape, my journey has been marked by strategic victories in both device and drug domains. Through spearheading successful submissions, ensuring rigorous compliance, and mentoring the next generation of regulatory professionals, my path reflects a balance of expertise and leadership. Beyond the compliance milestones, my passion lies in streamlining processes, fostering cross-functional collaboration, and driving innovation and efficiency within the regulatory framework. My approach is characterized by a relentless pursuit of excellence and a commitment to shaping the future of healthcare innovation, making every challenge an opportunity to advance the field.
Experience
Lead Regulatory Affairs Specialist
May 2024 — Present
Education
University of Sunderland
Bachelor's Degree
Skills
- Auditing
- Accounts Receivable
- Ifrs
- Ich
- Pharmaceutical Industry
- Accounts Payable
- E-Ctd Software
- Russian
- Microsoft Excel
- Microsoft Office
- Financial Repo
- Bilingual Communications
- Mathematics
- Management Accounting
- Regulatory Affairs
- Finance
- Standard Operating Procedure (Sop)
- Budgeting
- Ema Regulations
- Business Modeling
- U.s. Food and Drug Administration (Fda)
- Good Clinical Practice (Gcp)
- Quickbooks
- Financial Accounting
- Academic English
- Public Speaking
- Accounting
- Research
- Time Management
- Leadership
- Management
- Bilingualism
- Microsoft Word
- Team Leadership
- German Translation
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