Associate Dir, QARA MX N. Cluster

DePuy Synthes is recruiting for an Associate Director Quality Assurance & Regulatory Affairs (QARA) Mexico / Northern ClusterlocatedinMexico CityMexicoor Columbia.

The Associate Director Quality Assurance & Regulatory Affairs (QARA) Mexico / Northern Cluster provides strategic and operational leadership for quality assurance and regulatory affairs activities across Mexico and the Northern Cluster. This role is accountable for ensuring regulatory compliance effective quality management system execution and sustained market access for DePuy Synthes Orthopedics portfolio.

Thisis a highimpact leadership role with direct influence on product lifecycle decisions health authority interactions inspection readiness and regional QARA excellence. The role partners closely with crossfunctional leaders to translate regulatory and quality requirements into practical business solutions that support innovation growth and patient safety.

Key Responsibilities

• Lead and coordinate Quality Assurance and Regulatory Affairs activities for newmodified and marketed medical devices across Mexico and the Northern Cluster.

• Develop and execute integrated quality and regulatory strategies to support product registrations notifications approvals and longterm market sustainability including alignment with U.S. FDA and EU MDR pathways as applicable.

• Ensure compliance with local regulatory requirements applicable international standards and DePuySynthesquality management system policies and procedures.

• Prepare review and oversee highquality regulatory submissions technical documentation and registration files ensuring accuracy completeness andinspectionreadiness.

• Lead and support health authority interactions including presubmission and postsubmission meetings negotiations and responses to regulatory inquiries.

• Partner with Clinical Quality R&D Operations Supply Chain and Commercial teams to ensure regulatory and quality readiness for clinical trials manufacturing and product launches.

• Interpret and communicate regulatory and quality requirements policies and changes translating regulatory intent into clear actionable guidance for project teams.

• Establishmaintain and improve QARA policies procedures and SOPs to ensure sustained compliance and market support.

• Identify quality and regulatory risks and opportunities and proactively advise leadership on potential business and compliance impact.

• Mentor coach and develop QARA team membersbuildingregional capability accountability and a strong culture of quality and compliance.

• Ensuring proactive engagement and shaping of regional policy initiatives that are critical to business strategy continuity and growth.

Qualifications

Education

• Required:Bachelors degree in Physical Sciences Biological Sciences Engineering ora relatedfield.

• Preferred: Advanced degree (Mastersor equivalent) in a scientific technical or regulatory discipline.

Experience and Skills

Required:

• 810 years of progressive experience in Quality Assurance and/or Regulatory Affairs within the medical device industry withdemonstratedleadership responsibility.

• Proven experience with U.S. FDA and European medical device regulatory processes including submissions and health authority interactions.

• Strong working knowledge of medical device regulations quality system requirements and riskbased compliance principles.

• Demonstrated ability to lead crossfunctional teams and manage multiple QARA priorities in complex matrixed environments.

• Experience mentoring or managing regulatory and/or quality professionals.

• Strong leadership presence sound judgment and effective decisionmaking and problemsolving capabilities.

Preferred:

• Handson experience supporting product approvals inspections audits and regulatory issue management.

• Experience supporting orthopedic products and/or Class II/III medical devices.

• Demonstrated success in strategic decisionmaking in highly regulated environments.

• Prior experience managing regional or multicountry regulatory and quality scopes.

• Regulatory Affairs or Quality certifications (e.g. RAC or equivalent).

• Strong written and verbal communication skills with the ability to influence and negotiate with internal and external stakeholders.

Other

• Language: Fluency in English and Spanish.

• Travel:Moderate regional travel across LATAM markets

• Certifications: Regulatory Affairs or Quality certifications preferred but not.

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