Product Manager, Combination Products

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.

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