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Product Manager, R&D

Judge Group, Inc.

Morristown, New Jersey • Today

Contract

USD 125,000.00 - 140,000.00 per year

Data Product Manager

Arcadia

Remote • Today

Full-time

USD 127,000.00 - 175,000.00 per year

Product Change Manager

Stefanini

Remote or East Hanover, New Jersey • Today

Easy Apply

Contract

Market

IT Project Manager - R&D

Atlas

Remote or Tarrytown, New York • Today

Full-time

Senior Manager - Research and Development Accounting

Eliassen Group

Remote or Almont, Colorado • Today

Full-time

Principal Engineer, Early Innovation R&D

Johnson & Johnson

Raritan, New Jersey • Today

Full-time

USD 117,000.00 - 201,250.00 per year

Manager, R&D Data Steward

BeiGene, Inc.

Remote • Today

Full-time

USD 123,200.00 - 163,200.00 per year

Principal Research & Development (R&D) Engineer

Motorola Solutions

Remote or Los Angeles, California • Today

Full-time

USD 180,000.00 - 250,000.00 per year

Judge Group, Inc.

Job Details

Skills

Research and Development
ISO 13485
Regulatory Compliance
ISO 9000
Design Review
Due Diligence
Mechanical Engineering
Design Controls
Risk Management
Communication
Technical Writing
Presentations
Privacy
Marketing

Summary

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!

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: cxjudgpa
Position Id: 1155905
Posted 4 hours ago

Company Info

About Judge Group, Inc.

The Judge Group, is a leading professional services firm specializing in talent, technology, and learning solutions. We consult, staff, train, and solve. Through our work we make people and organizations better.

Our services are successfully delivered through a network of more than 30 offices across the United States, Canada, and India. The Judge Group is proud to partner with the best and brightest companies in business today, including over 60 of the Fortune 100. We serve organizations in financial services, healthcare, life sciences, insurance, government (including aerospace and defense), manufacturing, and technology and telecommunications.

Fitment

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Judge Group, Inc.

Job Details

Skills

Research and Development
ISO 13485
Regulatory Compliance
ISO 9000
Design Review
Due Diligence
Mechanical Engineering
Design Controls
Risk Management
Communication
Technical Writing
Presentations
Privacy
Marketing

Summary

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.

Dice Id: cxjudgpa
Position Id: 1155905
Posted 4 hours ago

Company Info

About Judge Group, Inc.

Fitment

Dice Job Match Score™

To see how well you match this job, please log in or create an account.

Once logged in, be sure to complete your profile to get the most accurate match score.

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

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