Clinical Manager

Job Role: Clinical Evaluations Manager

Location: Remote, United States.

Duration: 4 Months Contract only.

Overview

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.

Requirements:

• Experience: 3-5 years in clinical evaluations, medical physics, or related field

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