Clinical Evaluation Specialist-2

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

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 Evaluations Specialist, focus areas include:

• Execution of Clinical Evaluation and Post-Market Clinical Follow up support activities (may include customer surveys, literature searches, clinical studies)
• Support creation of Clinical Evaluation Plans/Reports and Post-Market Clinical Follow-up Plans/Reports (CEP/CER and PMCFP/PMCFR)
• Provide clinical perspective and input to cross-functional teams such as risk management, product management, and post-market surveillance
• Provide clinical review of promotional material and claims in support of publishing customer facing content
• Other duties, as assigned.

This position may suit you best if you are familiar with what is below, and would like to develop your skills with Healthineers:

• Familiarity with medical devices used in the field of radiation or interventional oncology
• Basic understanding of EU MDR and related guidance documents related to Clinical Evaluations and Post-Market Clinical Follow Up
• Familiarity with data analysis (e.g. literature appraisal, survey data) and statistical methods
• You have exemplary medical writing and verbal communication skills
• You prefer an autonomous working environment, as this position is remote
• You are able to prioritize and manage time demands, incomplete information, and unexpected events

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 Science, Engineering, or a Medical field; Master’s or PhD in Medical Physics , Biophysics, or Biomedical Engineering preferred. Other degree programs considered based on experience
• At least 2 years’ experience with clinical evaluations, medical writing, medical physics, or related field.
• Advanced knowledge of Microsoft Office, Word and Excel. Experience with reference manager software is preferred.

At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose:  To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.

This role will require flexible working hours to support cross-functional teams.

For posting in India: this role will require regular commitment to working within the Eastern US timezone for ~1/2 time

Who we are: We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

To find out more about Healthineers’ specific businesses, please visit our company page here.

As an equal opportunity employer, we welcome applications from individuals with disabilities.

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