Director, Combination Product & Device Development

Device Development:

• Lead end‑to-end development and commercialization of prefilled syringes, dual‑chamber cartridges, autoinjectors, and related combination product systems.
• Define user needs and product requirements; lead prototyping, test method development, and design verification and validation (DV/V) activities.
• Build and manage external relationships with CDMOs, device manufacturers, design firms, and suppliers to support development and lifecycle needs.

Design Controls & Human Factors:

• Serve as the organizational expert in Human Factors Engineering, ensuring compliance with IEC 62366, ANSI/AAMI HE75, FDA guidance, and related industry standards.
• Integrate usability, human performance considerations, and safety risk mitigations into system requirements and development strategies.
• Lead the cross‑functional design control sub‑team and drive cohesive integration across device design, analytical testing, packaging, manufacturing, clinical, supply chain, commercial, and regulatory functions.

Regulatory Support:

• Ensure compliance with global combination product and medical device regulations, including FDA and EU frameworks (e.g., EDDO, MDR).
• Author device‑related sections for regulatory submissions (BLA, MAA, IND/IMPD) and support notified body interactions.
• Represent the combination product function during regulatory audits and inspections.