Product Manager, Drug-Device R&D Leader

The Judge Group; Morristown (NJ); Presencial; USD 125.000 - 140.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Bonus

401k match

Dental

Vision

Descripción de la vacante

The Judge Group is seeking a Product Manager, R&D in Morristown, NJ to lead the development of drug-device combination products using design controls and risk management.

Responsibilities include preparing and updating the Design History File, reviewing DHF and risk management documents, and overseeing third-party design activities while serving as a subject matter expert for due diligence on injectable pens, inhalation, transdermal products and infusions.

Formación

• BS/MS in Engineering (Mechanical or Chemical) or equivalent required.
• 5-7 years in development of combination products (drug & device).
• 2-3 years with development of generic combination products preferred.
• Experience with DHF preparation, review or update desirable.
• Strong regulatory and design control experience.

Responsabilidades

• Design and development of combination products involving device and drug components using design controls.
• Preparation, review or update of DHF and risk management files.
• Monitoring and review of third-party design development activities and DHF documents.
• Subject matter expert for due diligence of combination products (injectable pens, inhalation, transdermal products, infusions, etc.).

Conocimientos

Communication skills

Design controls

Risk management

DHF documentation

Technical writing

Educación

BS/MS in Engineering (Mechanical or Chemical) or equivalent

Herramientas

21 CFR 820.30

ISO 13485:2016

ISO 14971:2019

Descripción del empleo

The Judge Group is seeking a Product Manager, R&D in Morristown, NJ to lead the development of drug-device combination products using design controls and risk management.

Responsibilities include preparing and updating the Design History File, reviewing DHF and risk management documents, and overseeing third-party design activities while serving as a subject matter expert for due diligence on injectable pens, inhalation, transdermal products and infusions.