Siemens Healthineers

Clinical Evidence Planning & Evaluations Manager

Siemens Healthineers$134K — $184K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Master's or PhD in Medical Physics, Biophysics, Biomedical Engineering, or related field
  • 3-5 years of experience in clinical evaluations, medical physics, or a related field
  • Understanding of EU MDR clinical evaluation and post-market follow-up requirements
  • Familiarity with design and manufacture of medical devices, particularly in radiation oncology
  • Excellent technical writing and verbal communication skills

Responsibilities

  • Create and execute the Clinical Evidence Strategy for Varian's devices
  • Develop Clinical Evaluation Plans and Reports, including CEP/CER and PMCFP/PMCFR
  • Provide clinical insights to regulatory and product management teams
  • Conduct Post-Market Clinical Follow-Up activities, including customer surveys and literature searches
  • Review promotional materials and claims for clinical accuracy

Benefits

  • Medical, dental, and vision insurance
  • 401(k) retirement plan
  • Life insurance
  • Long-term and short-term disability insurance
  • Paid parking/public transportation
  • Paid time off and sick leave
Full Job Description
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 This position may suit you best if you are familiar with what is below, and would like to develop your skills with Healthineers: - You have familiarity with design and manufacture medical devices, especially those used in the radiation oncology setting - You have exemplary technical writing and verbal communication skills - You prefer an autonomous working environment, as this position is remote. Required skills and education to have for the success of this role - 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. The base pay range for this position is: $134,300 - $184,668 Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate. If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance. The Company offers the following benefits for this position, subject to applicable eligibility requirements: 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. #LI-Remote

About Siemens Healthineers

Siemens Healthineers is a medical technology company that provides a range of medical devices and services. The company was founded in 2018 and is headquartered in Erlangen, Germany. Siemens Healthineers operates in over 70 countries and has over 54,000 employees. The company is a subsidiary of Siemens AG, a German multinational conglomerate. Siemens Healthineers has been recognized for its innovation and commitment to sustainability.
Learn more about Siemens Healthineers
Size
54,000 employees
Industry
Founded
2008

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