Rosario Borja Swing

About Rosario Borja Swing

Quality Assurance and Regulatory Affairs professional, with extensive experience in the Medical Device and Pharmaceutical industry, including project development, implementation and control, combined with the ability to research data and generate original reports from multiple business units, in line with FDA and various international regulatory agencies. Capable to quickly adapt to the position at hand, and support cross-functional teams. Self-motivated individual who embraces change, and welcomes new learning opportunities with ease. Strong communication, time management and organizational skills. Independent and efficient, with excellent coordinating abilities with other members of a regulatory team. Proficient in conducting business in English, Portuguese, and Spanish. TRANSFERABLE SKILLS• Quality and Safety Surveillance compliance.• Remediation compliance projects.• Regulatory Affairs reporting proficiency.• Provide regulatory support to cross-functional project teams in conjunction with direct manager.• Support international product registration activities worldwide.• Interact with global affiliates to assist with obtaining legalized registration documents.• Experienced in FDA / Regulatory Agencies reporting and auditing.• Clinical Evaluation Reports.• Training and motivating team members.• Medical language competence.• Electronic documentation structural design and management.• Client satisfaction driven.• Ability to manage and motivate co-workers.• Fluent, spoken and written, multi-lingual: English, Spanish, and Portuguese.• Computer skills include: Windchill,PQMS, SuPer, Oracle and Trackwise, customized Internet based complaint handling programs; Siebel based SouthStar complaint handling program, CAPA and Product Analysis processes for the medical device industry, used across the various Johnson & Johnson companies, among others.

Experience

1. Regulatory Affairs Specialist

   Johnson & Johnson MedTech

   Jan 2018 — Present · Miami, FL, US

   CERENOVUS, part of Johnson & Johnson Medical Devices Companies, is a global leader in neurovascular care. Our commitment to changing the trajectory of stroke is inspired by our long heritage and dedication to helping physicians protect people from a lifetime of hardship. CERENOVUS offers a broad portfolio of devices used in the endovascular treatment of hemorrhagic and ischemic stroke.The role of Regulatory Affairs Specialist, includes, but is not limited to:• Support / lead international product registration (510ks and PMAs) submissions activities worldwide.• Prepare required documents for international registration submissions, including Certificates to Foreign Government, Certificate of Analysis, Powers of Attorney, and Certificates of Free Sale, among other essential documents.• Interact with global affiliates RA and cross-functional project teams, Suppliers, and Health Authorities Organizations, to assist with obtaining legalized registration documents.• Provide international regulatory support regarding product design, manufacturing, packaging, sterilization, shelf life, Technical File and / or Design Dossiers, IFU and Labeling changes.• Provide / lead / guide international regulatory requirements to project teams, and regulatory staff, regarding essential documentation for their product(s) registrations and registration renewals submissions.• Maintain international regulatory affairs databases. • Provide regulatory support to cross-functional project teams in conjunction with direct Manager.• Supported the renewals of BSI CE Product’s Certifications (apostille or Embassy legalization), due to the BSI Headquarters transfer to the Netherlands, in 2019, achieving these renewals’ completion prior to the deadline established dates.

Education

• Universidade Federal do Rio Grande do Norte

  Nursing, Pediatric Nursing / General Nursing Care / Administration

Skills

• Design Control
• Validation
• Medical Devices
• Capa
• Management
• U.s. Food and Drug Administration (Fda)
• Design of Experiments
• Manufacturing
• Commercialization
• Biotechnology
• Strategy
• Change Control
• Product Development
• Software Documentation
• Root Cause Analysis
• Regulatory Requirements
• Quality System
• Iso 13485
• 21 Cfr Part 11
• Regulatory Submissions
• Leadership
• Healthcare
• Quality Assurance
• Regulatory Affairs
• Pma
• Quality Control
• Gmp
• Clinical Trials
• Quality Management
• Corrective and Preventive Action (Capa)
• Iso Standards
• Cross-Functional Team Leadership
• Iso 14971
• Training
• R&D
• Six Sigma
• Product Launch
• Quality Auditing
• Iso
• Pharmaceutical Industry