Product Manager, R&D (1155905)

The Judge Group; Morristown (NJ); On-site; USD 125,000 - 140,000; Full time

Benefits offered by this job

Bonus

401k match

Dental

Vision

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.).

Skills

Communication skills

Design controls

Risk management

DHF documentation

Technical writing

Education

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

Tools

21 CFR 820.30

ISO 13485:2016

ISO 14971:2019

Job description

Location: Morristown, NJ

Salary: $125,000.00 USD Annually - $140,000.00 USD Annually

Description: Our client is currently seeking a Product Manager, R&D who will be responsible for the development of drug-device combination products using design control and risk management processes.

This a permanent role eligible for additional rewards like bonus, 401k match, dental, vision etc.

This Job Will Have The Following Responsibilities

• Design and development of combination products involving device and drug constituent parts using the design control process (in compliance with 21 CFR 820.30 and ISO 13485:2016 section 7.3).
• Preparation, review or update of Design History File (DHF) and risk management file (in compliance with ISO 14971:2019) for the combination products
• Monitoring and review of device constituent part development at the third party design/development house(s) including design reviews and DHF documents review
• Subject matter expert for the due diligence of combination products such as injectable pens, inhalation products, transdermal products, infusions, etc.

Qualifications & Requirements

• BS/MS in Engineering (Mechanical or Chemical) or equivalent with 5-7 years of industry experience in the development of combination products (drug & device).
• Two to three years of experience with the development of generic combination products is preferable
• Experience in the preparation, review and/or update of DHF for combination products is desirable.
• Previous work experience should involve developing combination products using design controls including product risk management.
• Strong written and verbal communication skills, specifically in technical writing and oral presentations.
• Capable of working independently based on regulatory requirements, and company goals.