Director – Combination Product Program Lead

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the entire drug-device combination initiative from the design and verification of the device through to risk management and the management of the design history file.

• Develop strategy, create cohesive timelines, mitigate risks, and uphold scope, quality, and deadlines.

• Formulate the FDA regulatory strategy while balancing considerations between the device and drug.

• Ensure the program is always ready for inspections and submissions at every phase.

• Facilitate communication between pharmaceutical development and device engineering to ensure synchronized progress.

• Coordinate and engage scientific, regulatory, quality, clinical, and operations teams across various disciplines and levels of seniority.

• Act as the primary day-to-day liaison with the technology partner.

• Direct and integrate external consultants specializing in devices and regulatory affairs.

• Engage in practical technical problem solving involving electronics, software, electrochemistry, and delivery hardware.

• Report on progress, risks, and decisions to executive leadership.

⛳️ Requirements

• Proven track record in leading the technical development of a drug-device combination product that encompasses device design and engineering, verification and validation, human factors, and risk management for combination products.

• Experience in advancing specific combination products or delivery systems from early development stages through to design transfer, submission, or market launch.

• Substantial experience with FDA device regulations, including 21 CFR Part 4, design controls, and premarket submissions.

• Background in electrical engineering projects or a closely related discipline, demonstrating substantial technical expertise.

• Familiarity with pharmaceuticals and devices and their integration.

• Knowledge of quality systems for combination products (ISO 13485), risk management (ISO 14971), human factors/usability engineering (IEC 62366), requirements for on-body/wearable delivery systems (ISO 11608, including Part 6), and safety standards for medical electrical equipment (IEC 60601).

• Proven ability to lead teams and programs while also contributing technically.

• Skill in coordinating diverse specialists and collaborating with external partners and consultants.

• Confidence and credibility in presenting to and being challenged by senior leadership.

• Preferred technical expertise in areas such as electronics and embedded hardware design, software/firmware development, electrochemistry, and the development of implantable or body-worn devices, wearable/transdermal delivery devices, or management of combination product DHF/technical file/design control documentation.

• Ability to work iteratively, adapt swiftly, and make progress in uncertain environments.

• Capacity to build trust across organizations, take ownership, follow through, provide and receive direct feedback, and operate with urgency while ensuring quality and compliance.

🏝️ Benefits

• 99% of the premium covered for medical, dental, and vision insurance plans.

• Company-sponsored life insurance.

• Company-sponsored accidental death and dismemberment (AD&D) insurance.

• Disability benefits.

• Optional plans to customize coverage.

• Dollar-for-dollar 401(k) matching up to 6% on eligible contributions.

• Long-term stock incentives.

• Employee Stock Purchase Plan (ESPP).

• Discretionary quarterly bonuses.

• Highly flexible wellness benefits.

• Generous paid time off (PTO).

• Paid holidays.

• Company-wide shutdowns.