Director – Combination Product Program Lead

Praxis

. Drive the drug-device combination program end to end from device design and verification through risk management and design history file ownership .

Posted 9/23/2026full-timeRemote • United StatesSenior💰 $205,000 - $225,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in driving drug-device combination programs, integrating device design and regulatory strategy while ensuring compliance with FDA regulations and quality systems. Proven ability to lead cross-functional teams and manage complex projects from development through submission.

Highest-signal resume keywords

FDA Device Regulatory ExperienceCombination Product Risk ManagementISO 13485 Quality Systems KnowledgeElectronics and Embedded Hardware DesignTechnical Development Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Device DesignVerification and ValidationHuman Factors EngineeringDesign Control DocumentationElectrochemistrySoftware/Firmware DevelopmentCombination Product DHF OwnershipOn-Body Delivery System RequirementsMedical Electrical Equipment SafetyPremarket Submissions

Soft Skills

Cross-Functional Team LeadershipEffective CommunicationProblem SolvingBuilding TrustAdaptability

Industry Keywords

21 CFR Part 4ISO 14971IEC 62366ISO 11608IEC 60601

About the role

Key responsibilities & impact

Drive the drug-device combination program end to end from device design and verification through risk management and design history file ownership
Set strategy, build integrated timelines, manage risk, and maintain scope, quality, and deadlines
Shape the FDA regulatory strategy while coordinating device and drug considerations
Keep the program inspection ready and submission ready at every stage
Translate between pharmaceutical development and device engineering so both advance in lockstep
Align and mobilize scientific, regulatory, quality, clinical, and operations teams across disciplines and seniorities
Serve as the day-to-day interface with the technology partner
Direct and integrate external device and regulatory consultants
Perform hands-on technical problem solving across electronics, software, electrochemistry, and delivery hardware
Present progress, risks, and decisions to executive leadership

Requirements

What you’ll need

Personally led the technical development of a drug-device combination product spanning device design and engineering, verification and validation, human factors, and combination product risk management
Experience taking specific combination products or delivery systems from early development through design transfer, submission, or launch
Demonstrable FDA device regulatory experience, including 21 CFR Part 4, design controls, and premarket submissions
Background or experience in electrical engineering projects or a closely related field, with genuine technical depth
Working understanding of pharmaceuticals and devices and how they come together
Knowledge of combination product quality systems (ISO 13485), risk management (ISO 14971), human factors/usability engineering (IEC 62366), on-body/wearable delivery system requirements (ISO 11608, including Part 6), and medical electrical equipment safety (IEC 60601)
Evidence of leading people and programs while also delivering technical work personally
Ability to coordinate diverse specialists and work with external partners and consultants
Comfort and credibility presenting to and being challenged by senior leadership
Highly desirable technical breadth in electronics and embedded hardware design, software/firmware development, electrochemistry, implantable or body-worn device development, wearable/transdermal delivery device development, or combination product DHF/technical file/design control documentation ownership
Comfort operating iteratively, adapting quickly, and making progress amid ambiguity
Ability to build trust across organizations, take ownership, follow through, give and receive direct feedback, and work with urgency while maintaining quality and compliance

Benefits

Comp & perks

99% of the premium paid for medical, dental and vision plans
Company-paid life insurance
Company-paid AD&D
Disability benefits
Voluntary plans to personalize coverage
Dollar-for-dollar 401(k) matching up to 6% on eligible contributions
Long-term stock incentives
ESPP
Discretionary quarterly bonus
Extremely flexible wellness benefit
Generous PTO
Paid holidays
Company-wide shutdowns