Rahway, New Jersey
31 days ago
Design Control & Risk Management Lead
One of our large pharmaceutical clients is actively hiring a Design Control and Risk Management lead, supporting the Combination Product, Device Development Team. This project is focusing on autoinjectors and they will be
responsible for leading and implementing Medical Device & Combination Product Design Control & Risk Management activities for new products from early design concept, clinical and through commercialization. This position will interact with cross-functional development teams and within Device Development. This resource must be able to work well with all levels of employees and be able to effectively coordinate the execution of autoinjector device development strategies.


Responsibilities:
- Lead the creation of Device Development, Design Control and Risk Management deliverables for the assigned projects.
- Lead the implementation and/or ensures effective execution of the Device Development Strategy, Design Control and Risk Management activities for the assigned projects.
-Proactively resolve project obstacles and challenges
-Understand and apply regulatory / compliance requirements relative to design controls and risk management activities.
-Lead conversations with external suppliers

This is a hybrid role, 3 days onsite, 2 WFH.

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