Quality and Regulatory Affairs Director

CONFIDENTIAL RETAINED SEARCH | MEXICO LIFE SCIENCES

Search Reference: TNF-MX-QRA-2026 | Quality and Regulatory Leadership Mandate, Mexico Life Sciences

ABOUT THIS SEARCH

Top Notch Finders has been retained on an exclusive and strictly confidential basis to identify a Quality and Regulatory Affairs Director for a client in Mexico’s medical device, biotech, pharmaceutical, and techbio sector. To protect the interests of our client and of every candidate who engages with us, the identity of the company is disclosed only to qualified candidates under a confidentiality agreement. All inquiries and applications are received and managed solely by Top Notch Finders.

POSITION SNAPSHOT

• Company profile: Medical device or pharmaceutical manufacturer with operations in Mexico’s major life sciences clusters.
• Reports to: VP of Operations / Chief Compliance Officer.
• Location: Major Mexican life sciences cluster (Baja California, Jalisco, or Nuevo León); specifics disclosed to qualified candidates.

THE OPPORTUNITY

The Quality and Regulatory Affairs Director ensures organization-wide compliance with U.S. and Mexican medical device and pharmaceutical regulations, leading the transition to the FDA’s new Quality Management System Regulation (QMSR) and managing all regulatory submissions and audits. The mandate has become significantly more demanding following the February 2026 QMSR transition, which is the single largest driver of demand for quality leaders who can demonstrate granular fluency in ISO 13485:2016.

KEY RESPONSIBILITIES

• Ensure full compliance with ISO 13485:2016, FDA 21 CFR Part 820 / QMSR, and EU MDR as applicable.
• Lead the organization’s transition and re-certification under the FDA’s Quality Management System Regulation (effective February 2, 2026).
• Manage regulatory submissions and interactions with COFEPRIS and FDA.
• Oversee design assurance documentation and design history files supporting product approvals.
• Lead internal and external quality audits and drive corrective/preventive action (CAPA) processes.
• Build and mentor a quality and regulatory affairs team across multiple functions.
• Advise executive leadership on regulatory risk related to new product launches and manufacturing changes.

REQUIRED QUALIFICATIONS AND EXPERIENCE

• Bachelor’s degree in engineering, life sciences, or regulatory affairs; advanced certification (RAC) preferred.
• 7-10+ years of progressive quality and regulatory leadership in medical device or pharmaceutical manufacturing.
• Clause-level fluency in ISO 13485:2016 required, including experience managing the FDA QSR-to-QMSR transition.
• Direct experience with COFEPRIS and FDA submission processes.
• Strong audit management and CAPA process leadership experience.

CONFIDENTIALITY AND HOW TO APPLY

This is a discreet, retained engagement. Your candidacy will never be presented to any organization without your explicit prior authorization, and no application will be visible to the hiring company at this stage. Accomplished quality and regulatory leaders are invited to submit a resume in confidence, in English or Spanish, through the Top Notch Finders website. Please reference search code TNF-MX-QRA-2026 in your submission. Do not include patient-identifiable, trial-blinded, or other confidential clinical or proprietary information of any kind in your application materials. Only candidates whose backgrounds align closely with the mandate will be contacted.