Associate Director

Sanofi

. Lead HF/UE strategy and execution across multiple programs and business units .

Posted 11/6/2026full-timeUnited StatesSenior💰 $148,500 - $214,500 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Human Factors/User Experience (HF/UE) strategy, regulatory compliance, and user-centered design methodologies. Proven ability to lead complex HF/UE programs, mentor team members, and collaborate effectively across cross-functional teams.

Highest-signal resume keywords

10+ Years Experience In Medical Device HF/UEMastery Of FDA HF Guidance DocumentsGenerative Research Methods ExpertiseExperience Leading FDA SubmissionsStrategic Thinking And Cross-Functional Influence

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Human Factors EngineeringUsability EngineeringRisk AnalysisFormative Evaluation TechniquesSummative ValidationHF/UE Process ImplementationDesign ControlsRegulatory DocumentationTask AnalysisUse-Related Risk Analysis

Soft Skills

Excellent Communication SkillsMentoring And DevelopmentStrategic ThinkingCollaboration

Industry Keywords

FDAIEC 62366-1:2015+A1:2020ISO 14971:2019ISO 13485EMA GuidelinesCombination ProductsDesign ControlsRegulatory StrategyClinical PracticePost-Market Activities

About the role

Key responsibilities & impact

Lead HF/UE strategy and execution across multiple programs and business units
Drive user-centered design processes across the product portfolio
Shape and improve HF/UE processes, methodologies, tools, and templates
Lead generative, formative, and summative HF/UE studies, including design, protocols, execution, analysis, and reporting
Conduct and oversee use-related risk analysis, task analysis, known use problems analysis, and risk-control evaluation
Contribute to regulatory strategy and support health authority submissions and interactions
Mentor and develop HF/UE team members
Collaborate with design, regulatory, clinical, quality, and marketing teams
Ensure HF/UE compliance and best practices, including UEF/DHF deliverables, design controls, and regulatory documentation
Manage external vendors and consultants supporting HF/UE studies and program delivery

Requirements

What you’ll need

Bachelor's in Engineering, Human Factors Psychology, industrial design, Life sciences or related fields
10+ years of progressive experience in medical device, product human factors engineering, usability engineering, combination product human factors engineering or related fields
Mastery of FDA HF Guidance documents, IEC 62366-1:2015+A1:2020, ISO 14971:2019, ISO 13485, and EMA guidelines
Ability to lead and manage complex HF/UE programs across multiple concurrent projects with minimal oversight
Strategic thinking and ability to influence cross-functional teams and drive user-centric outcomes
Experience defining and implementing HF/UE processes, methodologies, and best practices
Expertise in generative research methods, formative evaluation techniques, summative validation, and use-related risk analysis
Excellent written and spoken English communication skills
Willingness to travel to study sites up to 20%
Preferred: Master's degree in Engineering, Human Factors Psychology, industrial design, Life sciences or related fields
Preferred experience beyond HF/UE in design disciplines, engineering fields, regulatory and risk management, requirements generation, clinical practice, or post-market activities
Experience leading FDA submissions and regulatory interactions with FDA, EMA, and Notified Bodies
Experience with portfolio-level HF/UE strategy and cross-functional governance
Knowledge of IFU and instructional design for combination products or medical devices

Benefits

Comp & perks

Opportunities for promotion or lateral moves, at home or internationally
Thoughtful rewards package
High-quality healthcare
Prevention and wellness programs
At least 14 weeks' gender-neutral parental leave
Professional development and career growth opportunities