Match score not available

Clinical Evaluations Manager (1061869)

Remote:

Full Remote

Contract:

Fixed term

Salary:

173 - 192K yearly

Experience:

Mid-level (2-5 years)

Work from:

Wisconsin (USA), United States

Offer summary

Qualifications:

3-5 years in clinical evaluations or related field, Master’s or PhD in Medical Physics preferred, Experience with regulatory standards (EU MDR, FDA), Oncology background with medical devices, Familiarity with medical device design and manufacturing.

Key responsabilities:

Create Clinical Evaluation Plans and Reports
Provide clinical input to cross-functional teams
Execute Post-Market Clinical Follow Up activities
Conduct clinical review of promotional materials
Jump into clinical revision reports for regulatory purposes

The Judge Group Human Resources, Staffing & Recruiting Large https://www.judge.com/

1001 - 5000 Employees

See more The Judge Group offers

Job description

Location: Milwaukee, WI, USA

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:
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)

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