Purpose of the Role:To lead and coordinate combination product-related activities across functional teams and projects, ensuring robust design, development, and usability of drug delivery systems, with a strong emphasis on human factors integration and regulatory readiness.
Key: bring everything together.
Roles and Responsibilities:Cross-Functional Coordination• Act as the central point of contact for combination product development across CMC, Regulatory, Quality, Clinical Supplies, and external partners
• Facilitate alignment of device strategy across multiple programs, ensuring consistency and scalability
• Lead regular device team meetings and ensure transparent communication of project status, risks, and milestones
Device Development & Lifecycle Management • Oversee design, industrialization, and lifecycle management of combination products including prefilled syringes and auto-injectors
• Drive design control activities including design input/output, verification, validation, and risk management
Human Factors Leadership • Coordinate formative and summative human factors studies in collaboration with internal teams and external providers
• Ensure integration of usability engineering into design and risk management processes
• Review and interpret human factors data to inform design decisions and regulatory submissions
Regulatory & Quality Interface • Contribute to regulatory submissions including authoring and reviewing device sections
• Ensure compliance with applicable standards (ISO 13485, ISO 14971, EU MDR, 21 CFR Part 820)
External Partner Management • Establish and maintain strong relationships with device manufacturers, usability consultants, and packaging suppliers
• Lead contracting and oversight of service providers for device-related activities
Required Experience & Skills:- Master degree and 15+ years of relevant experience
- Proven track record in medical device development, project management, and cross-functional leadership
- Deep understanding of human factors engineering and its application in combination product development
- Familiarity with global regulatory frameworks for medical devices and combination products
- Strong interpersonal and communication skills; ability to energize and align diverse teams
- Experience with autoinjector platforms (e.g., YpsoMate) is a plus
- 25% travel
#LI-Remote
For applicants in the United States: The annual base salary hiring range for this position is $188,000.00 - $258,500.00 USD. This range reflects our good faith estimate at the time of posting. Individual compensation is determined using objective, inclusive, and job-related criteria such as relevant experience, skills, demonstrated competencies and internal equity. This means actual pay may differ from the posted range when justified by these factors. Because market conditions evolve, pay ranges are reviewed regularly and may be adjusted to remain aligned with external benchmarks.
This job is eligible to participate in our short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies. It also includes a comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines.
