Clinical Evidence Planning & Evaluations Manager

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About the role

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 a remote role in the US and Canada with less than 25% travel requirements.

Responsibilities

• Create and drive the Clinical Evidence Strategy for Varian’s devices
• Develop Clinical Evaluation Plans, Reports, and Post-Market Clinical Evaluation Plans and Reports (CEP/CER and PMCFP/PMCFR)
• Provide 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, or Biomedical Engineering. Other degree programs considered based on experience
• 3-5 years’ experience with clinical evaluations, medical physics, or a related field

Skills

• Familiarity with design and manufacture of medical devices, especially those used in the radiation oncology setting
• Exemplary technical writing and verbal communication skills
• Ability to thrive in an autonomous, remote working environment

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) retirement plan
• Life insurance
• Long-term and short-term disability insurance
• Paid parking/public transportation
• Paid time off
• Paid sick and safe time

Pay

The base pay range for this position is $134,300 - $184,668. Factors which may affect starting pay within this range include geography/market, skills, education, experience, and other qualifications of the successful candidate. If this is a commission-eligible position, commission eligibility will be in accordance with the Company’s plan, based on individual and/or company performance.