Remote Clinical Evidence Strategy Manager

Siemens Healthineers; Austin (TX); On-site; USD 134,000 - 185,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Disability insurance

Paid parking/public transportation

Paid time off

Paid sick and safe time

Job summary

Siemens Healthineers is seeking a Clinical Evidence Strategy professional to create and drive the clinical evidence strategy, develop CEPs and PMCF plans, and provide clinical input across regulatory and product management teams.

This remote role in the US/Canada requires 3–5 years in clinical evaluations, medical physics, or related fields, and prefers a Master’s/PhD in Medical Physics, Biophysics, or Biomedical Engineering. Travel is <25% to support activities.

Qualifications

• Understanding of Clinical Evaluation and Post Market Clinical Follow Up requirements of class I-III medical devices (EU MDR)
• Master’s or PhD in Medical Physics/Biophysics/Biomedical Engineering; other degrees considered based on experience
• 3–5 years’ experience with clinical evaluations, medical physics, or related field

Responsibilities

• Create and drive the Clinical Evidence Strategy for Varian’s devices
• Create CEPs, CERs, and PMCF plans/reports (CEP/CER and PMCFP/PMCFR)
• Provide clinical perspective to cross-functional teams on clinical development, risk management, product management, and post-market surveillance
• Execute Post-Market Clinical Follow Up activities (e.g., literature search, clinical studies)
• Provide clinical review of promotional material and claims to support publishing customer-facing content

Skills

Medical device experience

Technical writing

Autonomous work

Radiation oncology familiarity

Education

Master’s or PhD in Medical Physics/Biophysics/Biomedical Engineering

Other degree considered based on experience

Job description

Siemens Healthineers is seeking a Clinical Evidence Strategy professional to create and drive the clinical evidence strategy, develop CEPs and PMCF plans, and provide clinical input across regulatory and product management teams.

This remote role in the US/Canada requires 3–5 years in clinical evaluations, medical physics, or related fields, and prefers a Master’s/PhD in Medical Physics, Biophysics, or Biomedical Engineering. Travel is <25% to support activities.