R&D Project Lead
Katalyst Healthcares and Life Sciences
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.
- 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.
- 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.
Vacancy posted 3 days ago
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