Job Summary
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.
Skill Requirements
- Strong understanding of EU MDR and medical device lifecycle requirements
- Knowledge of Design Controls, Risk Management (ISO 14971), and Clinical Evaluation
- Familiarity with UDI requirements and medical device data structures
- Strong project management skills (planning, risk management, stakeholder communication)
- Ability to work in a matrix organization
- Excellent problem‑solving and decision‑making capabilities
- Clear written and verbal communication skills
- Experience with project management and document management systems
- Comfortable working with regulatory databases and structured data submissions
- Detail‑oriented with strong compliance mindset
- Proactive and adaptable in regulatory‑driven environments
- Collaborative team player with a continuous improvement approach
Other Requirements
EDUCATION:
Bachelor’s degree in Engineering, Life Sciences, Biomedical Engineering, or related field
Master’s degree is a plus