Clinical Evaluator

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Quick Summary

Key Responsibilities

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Cambio is one of the Nordics' leading suppliers in e-health with a comprehensive offering for the entire health and care chain. Our e-health solutions supports health care professionals in their daily work and offer patients safer and more easily accessible care. We are proud to be an important part of Swedish healthcare. We are growing continuously and now have about 1000 employees in several countries.

As a Clinical Evaluator at Cambio, you will play an important role in ensuring that our medical devices are supported by robust clinical evidence and meet applicable requirements for clinical safety and performance.

You will independently plan and conduct clinical evaluations while working closely with a cross-functional Clinical Evaluation Team combining expertise in the device, its intended use and the relevant clinical area. You will collaborate with colleagues across Regulatory Affairs, Risk Management, Post-Market Surveillance, R&D, Product Management and Marketing.

The role gives you the opportunity to work across the medical device lifecycle and contribute to both regulatory compliance and the continued development of our clinical evaluation processes.

Responsibilities

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Plan, conduct and maintain clinical evaluations throughout the medical device lifecycle
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Develop and maintain Clinical Evaluation Plans and Clinical Evaluation Reports
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Conduct systematic literature reviews and critically assess clinical data and scientific evidence
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Evaluate clinical safety, performance and benefit-risk, integrating evidence from risk management, verification and validation, usability and other relevant activities
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Monitor emerging clinical evidence, identify residual clinical uncertainties and recommend, develop and conduct appropriate Post-Market Clinical Follow-up activities
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Support regulatory submissions and interactions with notified bodies

What We Offer

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✓The opportunity to work with state-of-the-art medical software that helps shape the future of healthcare

✓Challenging and evolving clinical work as new technologies, including AI, raise the bar for clinical evidence, safety and performance

✓The chance to influence how clinical evaluations are conducted at Cambio and contribute to the continued development of our clinical strategy

You have a strong scientific and analytical mindset and are comfortable working with complex clinical information and turning it into clear, well-founded conclusions.

You are quality-conscious and attentive to detail, with the ability to work independently and take ownership of your responsibilities. At the same time, you enjoy working as part of a team and collaborating with people from different areas of expertise. You are a clear and adaptable communicator, able to explain complex topics in a simple and understandable way depending on your audience.

At Cambio, we value initiative and personal growth. Our culture is built on Trust, Care and Together, and it is important that you recognize yourself in these values.

Requirements

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Experience working with clinical evaluation of medical devices, either leading or contributing to the clinical evaluation process
Experience working with the EU Medical Device Regulation (MDR) and relevant guidance documents
Experience in systematic literature reviews and critical appraisal of clinical and scientific data
Good understanding of clinical safety, performance and benefit-risk assessment
Excellent written and verbal communication skills in English and good communication skills in Swedish

Nice to Have

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Have experience working with medical device software
Have experience with Post-Market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF) or risk management
Have experience with clinical research methodology, clinical investigation design or biostatistics
Have experience assessing state of the art, benchmark devices or equivalence
Have experience with scientific literature databases such as Embase or Medline

Welcome to a company where healthcare is improved every day. Here you will work with leading technology in a collaborative, trusting and empowering environment where your contribution will be appreciated and celebrated. In our caring culture you will have the opportunity to pursue different paths of professional growth. Seize the opportunity to do the most important work of your life. Read more about us here!

A healthier tomorrow also means taking care of those who make it possible -explore our employee benefits