Description

You will lead end-to-end development and commercialization of high-concentration biologic delivery systems such as prefilled syringes and autoinjectors. This role involves hands-on technical leadership, design control, human factors engineering, and regulatory submissions for drug-device combination products.

Requirements

• Deep expertise in device design control, verification and validation, risk management, and combination product regulations
• Strong knowledge of global device standards (ISO 13485, IEC 62366, ANSI/AAMI HE75) and FDA guidance
• Successful track record supporting major regulatory submissions and notified body assessments
• Expertise in Human Factors Engineering and usability integration
• Experience managing multiple concurrent projects and cross-functional teams

Responsibilities

• Lead end-to-end development of prefilled syringes, autoinjectors, and combination product systems
• Serve as device SME across concept, feasibility, development, qualification, and launch phases
• Drive design control documentation, risk assessments, usability studies, and human factors integration
• Collaborate with internal teams and manage external relationships with CDMOs and device manufacturers
• Author device-related sections for regulatory submissions (BLA, MAA, IND/IMPD)