Provide regulatory leadership to support the successful introduction, maintenance, and compliance of DePuy Synthes medical devices in the Mexico market.
Lead and manage regulatory submission, approval, and lifecycle activities for medical devices in Mexico.
Develop and execute regulatory strategies that support new product introductions, product changes, and ongoing compliance.
Act as the primary regulatory liaison with Mexican health authorities, maintaining effective and professional working relationships.
Partner with Quality, Supply Chain, R&D, and Commercial teams to ensure regulatory compliance throughout the product lifecycle.
Support regulatory inspections, audits, and inquiries.
Requirements
Bachelor’s degree required in life sciences, engineering, or a related scientific discipline.
6–8 years of progressive experience in Regulatory Affairs within the medical device industry.
Strong knowledge of regulatory requirements and product lifecycle management for medical devices.
Proven experience preparing, submitting, and maintaining regulatory filings and approvals.
Ability to interpret regulations and translate regulatory requirements into practical business guidance.
Experience working in cross‑functional, matrixed environments.
Fluency in Spanish and English (written and verbal) required.