R&D Project Lead

Katalyst CRO; Raritan (NJ); On-site; USD 85,000 - 110,000; Full time

Job summary

Katalyst CRO in Raritan, New Jersey is looking for a professional to provide R&D Lifecycle Management (LCM) support for the MDR franchise initiative. The role entails ensuring successful closure of Design History Files (DHF) and implementing MDR-compliant product families across manufacturing sites.

The ideal candidate will have a Bachelor's degree in Engineering or Life Sciences and extensive experience in medical device R&D and regulatory roles. Strong project management skills and familiarity with EU MDR requirements are essential.

Qualifications

• 5+ years of experience in medical device R&D, regulatory, or quality roles.
• Proven experience leading cross-functional projects.
• Hands-on experience with EU MDR requirements.
• Strong understanding of EU MDR and medical device lifecycle requirements.

Responsibilities

• Provide R&D Lifecycle Management (LCM) support for the MDR franchise initiative.
• Support EUDAMED UDI data collection activities.
• Engage with cross-functional team members for proper documentation.
• Lead cross-functional project activities and support stakeholder communication.

Skills

Project management

Problem-solving

Decision-making

Detail-oriented

Education

Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, or a related field

Tools

Pharmaceutical

Adaptiv

Job description

• Provide R&D Lifecycle Management (LCM) support for the MDR franchise initiative to ensure successful closure of applicable Design History Files (DHF) and implementation of MDR-compliant product families across applicable Ethicon manufacturing sites.
• Support EUDAMED UDI data collection activities, collaborate with cross-functional teams, and ensure regulatory documentation is developed, approved, and maintained in compliance with project requirements.
• 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 applicable Ethicon manufacturing sites.
• Support manual data collection for EUDAMED UDI as per approved protocols and work with cross-functional teams for all Ethicon product families as required.
• Engage with cross-functional team members to ensure proper documentation is developed and approved in the PLM system.
• Escalate concerns, issues, or delays to Ethicon management as needed.
• Ensure completion of all assigned training courses within required timelines.
• Lead cross-functional project activities and support stakeholder communication.
• Support risk management, planning, and project execution activities.
• Work with regulatory databases and structured data submissions as required.

Job Summary

• Provide R&D Lifecycle Management (LCM) support for the MDR franchise initiative to ensure successful closure of applicable Design History Files (DHF) and implementation of MDR-compliant product families across applicable Ethicon manufacturing sites.
• Support EUDAMED UDI data collection activities, collaborate with cross-functional teams, and ensure regulatory documentation is developed, approved, and maintained in compliance with project requirements.

Roles & 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 applicable Ethicon manufacturing sites.
• Support manual data collection for EUDAMED UDI as per approved protocols and work with cross-functional teams for all Ethicon product families as required.
• Engage with cross-functional team members to ensure proper documentation is developed and approved in the PLM system.
• Escalate concerns, issues, or delays to Ethicon management as needed.
• Ensure completion of all assigned training courses within required timelines.
• Lead cross-functional project activities and support stakeholder communication.
• Support risk management, planning, and project execution activities.
• Work with regulatory databases and structured data submissions as required.

Education & Experience

• Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, or a related field.
• Experience in medical device R&D, regulatory, or quality roles.
• Proven experience leading cross-functional projects.
• Hands‑on experience with EU MDR requirements.
• Exposure to EUDAMED submissions or data preparation is highly preferred.
• Experience with Pharmaceutical and Adaptiv is highly preferred.
• 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, problem‑solving, and decision‑making skills.
• Experience with project management and document management systems.
• Comfortable working with regulatory databases and structured data submissions.
• Excellent written and verbal communication skills.
• Ability to work effectively in a matrix organization.
• Detail‑oriented with a strong compliance mindset and collaborative approach.