Solange Arias
Regulatory Affairs Senior Manager | Global Regulatory Consultant | Global Regulatory Manager | Quality Assurance Manager
- Role
- Senior Manager Regulatory Affairs Lad at Olympus Corporation
- Location
- Miami, FL, US
- LinkedIn followers
- 500 followers
About Solange Arias
I am a highly qualified and extensively trained Regulatory Affairs - Quality Assurance Professional with over 20 years of experience providing regulatory expertise on a regulatory submission and approval, RA lifecycle management, global regulatory strategy, regulatory intelligence and requirements, regulatory authority / notified bodies interactions, promotional material, compliance, product development, and regulatory strategic assessments. I possess an In-depth knowledge of regulatory/technical medical devices regulations (ANVISA, INMETRO, COFEPRIS, INVIMA, ANMAT, DIGEMID, EU MDR), complaints, adverse event reporting, quality management systems, ISO 13485, MDSAP and 21 CFR 820. I have an eloquent communication skill to effectively Interact with regulatory agencies in order to resolve regulatory matters, and communicate information or updates to internal/external stakeholders for multiple projects at all status of prior and post approval.The different job positions that I have performed in over the years demonstrates that I have been a high-energy and confident professional with great enthusiasm for regulatory affairs, I am able to manage time, communication and resources effectively to accomplish complex tasks. When I get into a job, I want to know everything. What can we do? How can we do it? The devil is often in the details, so I make sure to be precise and detail-oriented. I strive to build my reputation at work by keeping open lines of communication with teammates and folks in different functional roles to find out what they know and how best to work with them. I can be described as a visionary, goal-oriented and a gifted critical thinker known for discipline, tireless work ethic, and enthusiastic embrace of new challenges, and for willingness to go the extra mile to deliver the very best.
Experience
Senior Manager Regulatory Affairs Lad
Nov 2023 — Present · Miami-Fort Lauderdale, FL, US
Education
Universidad Santo Tomás
Quality Auditor, ISO 9001:2000
Universidad Nacional de Colombia
MD, Pharmaceutical Chemist.
Universidad Santo Tomas de Aquino
MS, Specialist in Management and Administration of Quality Systems
Skills
- Recalls
- Mdrs
- Validation
- Regulatory Requirements
- Medical Devices
- Capa
- Regulatory Agencies
- Latin American Business
- Iso 13485
- Distributors
- Complaint Management
- Quality System
- Global Regulatory Compliance
- Gmp
- Sop Development
- Quality Assurance
- Design Control
- Regulatory Documentation
- Regulatory Affairs
- Compliance
- 21 Cfr
- Regulatory Submissions
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