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Research Development Project Lead
Job in
Newark, Essex County, New Jersey, 07175, USA
Listed on 2026-06-07
Listing for:
HCLTech
Full Time
position Listed on 2026-06-07
Job specializations:
-
Research/Development
Research Scientist -
Healthcare
Job Description & How to Apply Below
R&D Project Lead (Onsite) with 10+Yrs of Experience (E2.2/E3.1)
Experience in medical device R&D, regulatory, or quality roles
Experience in JnJ and Adaptiv is highly preferred
Proven experience leading cross‑functional projects
Hands‑on experience with EU MDR requirements
Exposure to EUDAMED submissions or data preparation is highly preferred
Key Responsibilities- Provide R&D LCM support to the MDR franchise initiative to successfully close applicable Design History Files (DHF) leading to the implementation of MDR compliant product families in the applicable ETHICON manufacturing sites.
- Provide R&D LCM support in the manual data collection for EUDAMED UDI per approved protocol and work with cross functional team for all Ethicon Product families as required.
- Engage with the cross‑functional team members as required to ensure proper documentation is developed and approved in the PLM system as well as escalation of any concerns, issues or delays to Ethicon management.
- Ensure to complete all required assigned training courses on time.
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