PABLO ALFONSO REYES GUZMAN
Industrial Pharmaceutical Chemist
Mexico City
Summary
Regulatory Affairs Specialist with 8+ years of experience managing medical device registrations and ensuring compliance across LATAM. Skilled in remote and hybrid operations, aligning local regulations with global frameworks like EU MDR, and proficient in systems such as Salesforce, Samarid, Agile, OnePLM, and Rimsys.
Proven success in leading projects on rebranding, country of origin compliance, and Class I-III device registrations. Adept at cross-functional collaboration, stakeholder communication, and delivering precise regulatory submissions to drive business growth and compliance.
Overview
8
8
years of professional experience
6
6
years of post-secondary education
1
1
Language
Work History
Regulatory Affairs Specialist
Stryker Mexico
Mexico City
07.2023 - Current
- Managed regulatory submissions for product registration across Spine, Trauma, Endoscopy, Trauson, and Medical franchises in Mexico and LATAM.
- Led the Country of Origin Project for the Spine and Wright Medical Technology franchises, ensuring compliance with Mexican regulatory requirements and mitigating potential import risks.
- Successfully executed the 2024 regulatory plan on time, aligning with company objectives and local regulations.
- Created Market Update notifications to track competitor product approvals, supporting strategic initiatives.
- Developed risk mitigation strategies in collaboration with cross-functional teams, ensuring compliance with regional regulations.
Regulatory Affairs Specialist
Becton Dickinson
Mexico City
01.2023 - 06.2023
- Ensured regulatory compliance for product registrations in Mexico, Central America, and the Caribbean, aligning with EU MDR requirements.
- Prepared and submitted 20 regulatory files for modifications, including brand changes, new catalog numbers, and manufacturer updates.
- Utilized Salesforce for document management, ensuring accurate tracking and submission of regulatory data.
- Collaborated with cross-functional teams to streamline processes, reducing regulatory approval timelines.
- Contributed to Market Update notifications, highlighting competitor product approvals in Mexico.
Quality and Regulatory Affairs Specialist
Cardinal Health
Mexico City
09.2020 - 01.2023
- Operated remotely, managing regulatory affairs across LATAM regions, including Mexico, Peru, Central America, and the Caribbean, overseeing 20-30 projects.
Led the Cordis brand rebranding project, successfully securing product approvals and ensuring regulatory compliance, managing 10-15 projects.
Prepared regulatory files for product registrations in Peru, the Dominican Republic, and the Caribbean, meeting local regulatory requirements and managing 10-15 projects.
Proficiently utilized Samarid, Agile, and OnePLM, and participated in the transition training from Samarid to Rimsys.
Conducted four audits and maintained consistent communication with regional teams to ensure operational compliance.
Senior Regulatory Affairs Analyst
ISA Health
Mexico City
10.2016 - 08.2020
- Worked remotely to manage regulatory submissions in Mexico, Colombia, and Chile, overseeing 90-120 projects and ensuring timely approvals.
Trained new team members to manage regulatory submissions for Class I, II, and III medical devices.
Utilized regulatory management systems to ensure compliance and streamline submission processes.
Provided regulatory guidance and updates to national and international clients, building strong professional relationships.
Education
Post-Baccalaureate Diploma - Administrative Law
Universidad Intercontinental
Mexico, México, Mexico 09.2024 - Current
Master of Science - Project Management
Universidad Virtual Del Estado De Guanajuato UVEG
Guanajuato City, Guanajuato, Mexico 08.2024 - Current
Master of Science - Administration of Productivity And Quality Systems
Universidad Simón Bolívar
Mexico, México, Mexico 08.2022 - 03.2023
Bachelor of Science - Industrial Pharmaceutical Chemist
National Polytechnic Institute
Mexico, México, Mexico 08.2011 - 12.2015
Skills
Global regulatory compliance
Regulatory agency applications
Analytical
Discipline
Responsability
Learner
Focus
Timeline
Post-Baccalaureate Diploma - Administrative Law
Universidad Intercontinental
09.2024 - Current
Master of Science - Project Management
Universidad Virtual Del Estado De Guanajuato UVEG
08.2024 - Current
Regulatory Affairs Specialist
Stryker Mexico
07.2023 - Current
Regulatory Affairs Specialist
Becton Dickinson
01.2023 - 06.2023
Master of Science - Administration of Productivity And Quality Systems
Universidad Simón Bolívar
08.2022 - 03.2023
Quality and Regulatory Affairs Specialist
Cardinal Health
09.2020 - 01.2023
Senior Regulatory Affairs Analyst
ISA Health
10.2016 - 08.2020
Bachelor of Science - Industrial Pharmaceutical Chemist
National Polytechnic Institute
08.2011 - 12.2015
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