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Clinical Evidence Planning & Evaluations Manager
Siemens HealthineersClinical evidence manager shaping evaluations and post-market follow-up for Varian radiation-oncology devices. Advising Siemens Healthineers’ regulatory, product, and Medical Affairs teams.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in developing Clinical Evaluation Plans and Reports, as well as Post-Market Clinical Follow-Up Plans and Reports for medical devices. Possesses strong technical writing and communication skills, with a solid understanding of EU MDR requirements for Class I–III medical devices.
Highest-signal resume keywords
Clinical Evaluation PlansPost-Market Clinical Follow-UpMedical Device Regulation (EU MDR)Technical WritingMedical Physics
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical EvaluationPost-Market SurveillanceRisk ManagementClinical StudiesCustomer SurveysLiterature SearchesMedical Device DesignRadiation OncologyClinical Evidence StrategiesTechnical Communication
Soft Skills
Self-DrivenAutonomous Working StyleVerbal Communication
Industry Keywords
Medical DevicesClinical AffairsBiophysicsBiomedical EngineeringMedical PhysicsCross-Functional TeamsPromotional MaterialsCustomer-Facing ContentPost-Market ActivitiesClinical Input
About the role
Key responsibilities & impact- Create and drive clinical evidence strategies for Varian’s devices
- Develop Clinical Evaluation Plans and Reports and Post-Market Clinical Follow-Up Plans and Reports (CEP/CER and PMCFP/PMCFR)
- Provide clinical perspective and input to cross-functional teams on clinical development, risk management, product management, and post-market surveillance
- Execute post-market clinical follow-up activities, including customer surveys, annual literature searches, and clinical studies
- Review promotional materials and claims for customer-facing content
- Expand the impact of Medical Affairs work across the organization
Requirements
What you’ll need- Familiarity with design and manufacture of medical devices, especially those used in the radiation oncology setting
- Exemplary technical writing and verbal communication skills
- Understanding of Clinical Evaluation and Post Market Clinical Follow Up requirements for Class I–III medical devices under 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
- Self-driven and autonomous working style
- Ability to work remotely in the US and Canada
- Less than 25% travel
Benefits
Comp & perks- Flexible benefits plan
- Defined Contribution Pension Plan
- Registered Retirement Savings Plan matching contributions
- Competitive paid time off program
- Vacation
- Company holidays
- Sick leave
- Parental leave
- Flexible and dynamic work environment
- Professional and personal growth opportunities