R&D Project Lead

Katalyst Healthcares and Life Sciences

Raritan, NJ

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.
bility to work effectively in a matrix organization.
Detail-oriented with a strong compliance mindset and collaborative approach.

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Vacancy posted 1 day ago

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