Clinical Evaluations Manager
The Judge Group Inc.

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

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