Job Info
Location: REMOTE
Salary: $90.00 USD Hourly - $100.00 USD Hourly
Description: Our client is currently seeking a Clinical Evaluations Manager for a 6 month contract.
Position Details
• Role: Senior Clinical Evaluations Manager
• Duration: Until end of February 2025
• Location: Remote (normal working hours)
• Travel: No Requirements
• Experience: 3-5 years in clinical evaluations, medical physics, or related field
• Skills:
o Must-Have:
• Experience managing the entire Clinical Evaluation Report (CER) process
• Oncology background with medical devices
• Cross-functional leadership and communication
• Regulatory awareness (EU MDR and FDA clinical evidence and evaluations)
o Nice-to-Have:
• Experience with medical software devices
• Project management and EU clinical evaluation experience, especially with radiation oncology devices
Additional Information
• Work Hours: standard hours in their time zones
• Location: Remote position, based anywhere in North America
• Additional Skills: Ability to jump into clinical revision reports for regulatory purposes, CRE experience with software devices. This is a role well suited for a self-driven professional looking to expand the impact of Medical Affairs work across the organization.
As a Clinical Evaluations Manager, you will be responsible for:
• Creation of Clinical Evaluation Plans, Reports, and Post-Market Clinical Evaluation Plans, and Reports (CEP/CER and PMCFP/PMCFR)
• Providing clinical perspective and input to cross-functional teams such as risk management, product management, and post-market surveillance
• Execute Post-Market Clinical Follow Up activities (may include customer surveys, annual literature searches, clinical studies)
• Provide clinical review of promotional material and claims in support of publishing customer facing content
This position may suit you best if you are familiar with what is below:
• You have familiarity with design and manufacture medical devices, especially those used in the radiation oncology setting
• You have exemplary technical writing and verbal communication skills
• You prefer an autonomous working environment, as this position is remote.
Required skills and education to have for the success of this role
• Understanding of Clinical Evaluation and Post Market Clinical Follow Up Requirements of class I-III medical devices as designated in the European Union Medical Device Regulation (EU MDR)
• Master's or PhD in Medical Physics (preferred), Biophysics, Biomedical Engineering. Other degree programs considered based on experience
• 3-5 years' experience with clinical evaluations, medical physics, or related field.
Contact: eronan@judge.com
This job and many more are available through The Judge Group. Find us on the web at www.judge.com