Clinical Evidence Planning & Evaluations Manager

Siemens Healthineers

8d•$134,300 - $184,668•Remote

About The Position

This person will create and drive clinical evidence strategies, develop clinical evaluation plans and reports, and provide clinical input across regulatory and product management teams. Post-market clinical follow-up activities and clinical review of promotional materials are also key responsibilities. This is remote role in the US and Canada with less than 25% travel requirements. 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 Evidence Planning and Evaluations Manager, you will be responsible for: Creating and driving the Clinical Evidence Strategy for Varian’s devices 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 regarding clinical development, 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

Requirements

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.

Nice To Haves

Familiarity with design and manufacture medical devices, especially those used in the radiation oncology setting
Exemplary technical writing and verbal communication skills
Prefer an autonomous working environment, as this position is remote.

Responsibilities

Creating and driving the Clinical Evidence Strategy for Varian’s devices
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 regarding clinical development, 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