R&D Manager, Drug/Device Combination
sciproBoonton, NJ
R&D Manager, Drug/Device Combination
sciproBoonton, NJManager L7
Pharmaceutical Preparation ManufacturingResearch and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)Research and Development in Biotechnology (except Nanobiotechnology)
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We are seeking a Combination Product Development Manager to support the development of drug-device combination products. This role is responsible for managing product design, risk management, and regulatory documentation. The position will work closely with internal teams and external partners to ensure products are safe, effective, and compliant.
Reporting Structure:
This role reports to the Executive Director, External R&D and works with Quality, Regulatory, Clinical, Supply Chain, and external design firms, manufacturers, and suppliers.
Key Responsibilities:
- Support the design and development of drug-device combination products using design control processes
- Prepare, review, and maintain Design History Files (DHF) and risk management documentation
- Work with external partners to review product designs and development progress
- Provide technical support for combination products such as injectors, inhalers, transdermal systems, and infusion devices
- Ensure documentation meets regulatory and quality requirements
- Support product risk assessments, complaint investigations, and product improvements
- Partner with Quality and other teams to maintain compliant product files
- Stay current with regulatory requirements and industry standards
Qualifications:
- BS or MS in Mechanical Engineering, Chemical Engineering, or related field5–7 years of experience developing drug-device combination products
- Injectables or autoinjectors experience highly preferred
- Experience with design controls and risk management
- Experience with Design History Files (DHF) preferred
- Strong communication and technical writing skills
- Ability to work independently and work with cross-functional teams
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Level
Manager L7
Location
Boonton, NJ
Occupation
Regulatory Affairs Managers
Industry
Pharmaceutical Preparation Manufacturing
Posted
8 days ago