R&D Drug-Device Product Manager | Design Control & Risk

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

Benefits offered by this job

Bonus

401k match

Dental

Vision

Job summary

Judge Group, Inc. is seeking a Product Manager, R&D to lead development of drug-device combination products using design control and risk management practices. This permanent role offers a competitive salary and bonus potential.

The successful candidate will manage design histories and risk files, oversee third-party development activities, and act as a subject matter expert on injectable pens and related delivery systems, while communicating complex technical concepts clearly.

Qualifications

• Experience with design controls for drug-device combinations.
• Familiar with DHF and risk management file updates.
• Strong written and verbal communication skills for technical documents and presentations.
• Ability to work independently to meet regulatory requirements and company goals.

Responsibilities

• Design and develop drug-device combination products using design control processes.
• Prepare, review, or update Design History File (DHF) and risk management file.
• Monitor and review third-party design/development activities and DHF documents.
• Serve as subject matter expert for due diligence of injectable pens, inhalation, transdermal products, etc.

Skills

Design control

Risk management

Regulatory documentation

Technical writing

Oral presentations

Education

BS/MS in Engineering (Mechanical or Chemical)

Job description

Judge Group, Inc. is seeking a Product Manager, R&D to lead development of drug-device combination products using design control and risk management practices. This permanent role offers a competitive salary and bonus potential.

The successful candidate will manage design histories and risk files, oversee third-party development activities, and act as a subject matter expert on injectable pens and related delivery systems, while communicating complex technical concepts clearly.