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R&D Project Lead

Katalyst Healthcares & Life Sciences

  • Raritan, NJ
  • 30+ days ago
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    Skills

    • Biologyunmatched
    • Biomedical Engineeringunmatched
    • Biotech and Pharmaceuticalunmatched
    • Clinical Assessmentunmatched
    • Clinical Trialunmatched
    • Communication Skillsunmatched
    • Cross-Functionalunmatched
    • Data Collectionunmatched
    • Data Structuresunmatched
    • Detail Orientedunmatched
    • Document Managementunmatched
    • Documentationunmatched
    • ISO (International Organization for Standardization)unmatched
    • Leadershipunmatched
    • Maintain Complianceunmatched
    • Manufacturingunmatched
    • Matrix Managementunmatched
    • Medical Equipmentunmatched
    • Presentation/Verbal Skillsunmatched
    • Problem Solving Skillsunmatched
    • Product Lifecycle Managementunmatched
    • Project Executionunmatched
    • Project/Program Managementunmatched
    • Regulationsunmatched
    • Regulatory Complianceunmatched
    • Research & Development (R&D)unmatched
    • Risk Managementunmatched
    • Structured Dataunmatched
    • Support Documentationunmatched
    • Team Playerunmatched
    • Writing Skillsunmatched

    Description

    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.

    Numbers & Facts

    LocationRaritan, NJ

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