Director, Combination Product - Seattle, WA

Only for registered members Seattle, WA, United States

1 day ago

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Job summary

Jade Biosciences is seeking a Director of Combination Product & Device Development to lead the development and commercialization of high-concentration biologic delivery systems.

We are looking for an experienced professional with expertise in device design control, verification and validation, risk management, combination product regulations, human factors engineering.

The ideal candidate will have hands-on technical leadership experience with regulated devices and combination products (21 CFR 820, ISO 13485), as well as strong knowledge of global device standards (ISO, IEC 62366) and FDA guidance.

Responsibilities

  • Lead end-to-end development and commercialization of prefilled syringes.
  • Serve as a hands-on technical leader across concept feasibility development qualification launch phases.

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