Clinical Evidence Planning & Evaluations Manager

🔥 0 minutes ago

🌐 Canada, United States – Remote

🇨🇦 Canada – Remote 🇺🇸 United States – Remote

💵 $93k - $132k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 0%

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Siemens Healthineers

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

⚕️ Healthcare Insurance

🧬 Biotechnology

💰 $1.5M Grant on 2021-05

Healthcare • Healthcare Insurance • Biotechnology

Siemens Healthineers is a leading MedTech company focused on pioneering breakthroughs in healthcare. They offer a comprehensive portfolio that addresses the entire care continuum for serious diseases, including medical imaging, laboratory diagnostics, point-of-care testing, and digital health solutions. With a commitment to innovation, sustainability, and improving patient access to care, Siemens Healthineers collaborates with healthcare professionals and organizations globally to advance medical technology and enhance patient outcomes.

📋 Description

• 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

• 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

• 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