Director – Combination Product Program Lead

Job not on LinkedIn

🔥 12 hours ago

🇺🇸 United States – Remote

💵 $205k - $225k / year

⏰ Full Time

🟠 Senior

👔 Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 20%

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Praxis

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2002

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Praxis is a company dedicated to connecting patients with meaningful clinical trial opportunities. With a focus on creating customized recruitment programs, Praxis utilizes a variety of specialized tools and extensive experience across various therapeutic areas to ensure they reach the right patients worldwide. Established in 2002, the company emphasizes the importance of patient engagement and utilizes sophisticated data insights to enhance the patient journey in clinical research.

📋 Description

• 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

• 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

• 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