Job Description: • 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 Clients 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. Experience: 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 Knowledge & Skills: Technical & Regulatory 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 Project & Leadership Skills Strong project management skills (planning, risk management, stakeholder communication) Ability to work in a matrix organization Excellent problem solving and decision making capabilities Communication & Tools Clear written and verbal communication skills Experience with project management and document management systems Comfortable working with regulatory databases and structured data submissions Behavioral Competencies Detail oriented with strong compliance mindset Proactive and adaptable in regulatory driven environments Collaborative team player with a continuous improvement approach Education Bachelor’s degree in Engineering, Life Sciences, Biomedical Engineering, or related field | 
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