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
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
As a VEVRAA Federal Contractor, APN Software is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. APN complies with applicable state and local laws governing nondiscrimination in employment.