Lead regional compliance and safety operations for pharmaceutical and medical device products across Latin America, Central America, and the Caribbean. This role oversees end-to-end management of quality complaints, adverse events, field safety reports, and regulatory submissions, ensuring alignment with international standards including ISO 13485, pharmacovigilance (PV), and technovigilance (TV) requirements.
Key Responsibilities
- Direct the regional team responsible for complaint intake, investigation, follow-up, documentation, and closure across LACAR countries.
- Serve as the primary regional expert for vigilance activities, providing guidance to local affiliates and escalating critical issues when necessary.
- Ensure timely processing of adverse events, serious adverse events, and field safety notifications in coordination with global teams and external partners.
- Oversee regulatory reporting obligations and support audit readiness for health authority inspections related to quality and safety processes.
- Monitor performance metrics, enforce service level agreements, and maintain data integrity within corporate reporting systems.
- Lead root cause investigations, risk assessments, and corrective action plans in response to emerging safety trends or recurring issues.
- Collaborate with Global Quality, Regulatory Affairs, Supply Chain, and Commercial functions to ensure consistent application of procedures across regions.
- Support training development and onboarding initiatives for regional teams on complaint handling and vigilance protocols.
- Advise internal stakeholders on the impact of new regulations on company policies and operational processes.
- Drive continuous improvement by identifying opportunities to streamline and harmonize regional workflows while maintaining compliance.
Qualifications and Experience
Candidates must hold a bachelor’s degree in pharmacy, life sciences, or a related healthcare field, with at least five years of experience in quality assurance, pharmacovigilance, or complaint management within the pharmaceutical or medical device industry. Demonstrated leadership in managing multicultural teams across multiple countries is essential. Fluency in both English and Spanish is required; proficiency in Portuguese is an advantage. Familiarity with Quality Management Systems and regulatory frameworks such as ISO 13485 and regional PV/TV guidelines is expected.
Work Environment
This hybrid position is based in Mexico City, with flexible working hours and remote options allowing up to two days per week offsite. The role supports a globally connected organization with diverse teams and cross-regional collaboration. The company promotes an inclusive culture focused on innovation, patient impact, and professional growth.
