Combo Product Manager - Drug/Device R&D

Alvogen; New Jersey; On-site; USD 130,000 - 140,000; Full time

Benefits offered by this job

Annual bonus

Medical & prescription coverage

Dental & Vision

HSA/HDHP

Retirement program

PTO 176 hours

Disability benefits

Life insurance

Wellness program

Paid holidays

Job summary

Alvogen is seeking a Combination Product Manager, R&D, in New Jersey. The role leads design controls for drug-device combinations, reviews DHF and risk management files, and performs due diligence on new products.

The candidate will liaise with QA, Regulatory, Clinical, PV, and Supply Chain while overseeing third-party design centers and CMOs. A strong cross-functional communicator with 5–7 years of relevant experience is required.

Qualifications

• BS/MS in Engineering (Mechanical or Chemical) or equivalent.
• 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 preparing, reviewing and updating Design History Files (DHF) for combination products.

Responsibilities

• Design and develop combination products using design control.
• Prepare, review or update Design History File (DHF) and risk management file (ISO 14971:2019).
• Monitor third party design/development and review DHF documents.
• Serve as SME for due diligence of combination products (injectable pens, inhalation products, transdermal products, infusions).
• Contribute to updating commercial design and risk files as needed.
• Partner with Third Party Quality to ensure DHF and Risk Management Files are complete and compliant.
• Support complaint management and pharmacovigilance to assess product risks.
• Stay informed on FDA, EU and ICH guidelines on drug-device combinations.

Skills

Design controls

Risk management

Technical writing

Oral presentations

Independent work

Regulatory awareness

Education

Engineering degree (Mechanical or Chemical)

Job description

Alvogen is seeking a Combination Product Manager, R&D, in New Jersey. The role leads design controls for drug-device combinations, reviews DHF and risk management files, and performs due diligence on new products.

The candidate will liaise with QA, Regulatory, Clinical, PV, and Supply Chain while overseeing third-party design centers and CMOs. A strong cross-functional communicator with 5–7 years of relevant experience is required.