Clinical Evaluations Manager - Remote

Campus4Tech; Washington (District of Columbia); Remote; USD 90,000 - 130,000; Full time

Job summary

A leading healthcare technology company seeks a Clinical Evaluations Manager to oversee the Clinical Evaluation Report process and collaborate with various teams. The ideal candidate will possess an understanding of medical device regulations and have experience in clinical evaluations, specifically within oncology. This remote role offers an opportunity for self-driven professionals looking to enhance the impact of medical affairs across the organization.

Qualifications

• 3-5 years experience in clinical evaluations, medical physics, or related field.
• Understanding of Clinical Evaluation and Post Market Clinical Follow Up Requirements of class I-III medical devices.
• Familiarity with medical devices, especially in radiation oncology.

Responsibilities

• Manage the entire Clinical Evaluation Report process.
• Provide clinical perspective to cross-functional teams.
• Execute Post-Market Clinical Follow Up activities.

Skills

Cross-functional leadership

Regulatory awareness

Communication

Education

Master's or PhD in Medical Physics

Biomedical Engineering

Biophysics

Job description

Position Details

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 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, And Would Like To Develop Your Skills With Healthineers:

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.