Product Manager, R&D

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.

By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes. Message & data rates apply and message frequency may vary. Consistent with Judge's Privacy Policy, information obtained from your consent will not be shared with third parties for marketing/promotional purposes. Reply STOP to opt out of receiving telephone calls and text messages from Judge and HELP for help.
Contact:
This job and many more are available through The Judge Group. Please apply with us today!