MDR 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

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.