Clinical Evidence Planning & Evaluations Manager
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.
Benefits
- flexible benefits plan
- Defined Contribution Pension Plan
- Registered Retirement Savings Plan matching contributions
- competitive paid time off program including vacation, company holidays, sick leave, and parental leave
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
