Contract Clinical Evaluation Report (CER) Writer – SaMD, AI & Digital Health
We are seeking an experienced CER Writer to support the development of two Clinical Evaluation Reports (CERs) for new Class IIa and Class IIb Software as a Medical Device (SaMD) products in the digital health and mental well-being space. This contractor will independently drive the clinical evaluation strategy and deliver MDR-compliant documentation suitable for Notified Body review.
Key Responsibilities
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Author two complete CERs and supporting Clinical Evaluation Plans (CEPs) for Class IIa and Class IIb devices.
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Conduct literature searches, clinical evidence reviews, and state-of-the-art assessments.
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Evaluate clinical safety, performance, usability, and benefit-risk data.
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Assess evidence supporting AI-enabled software functionality and clinical claims.
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Collaborate with Regulatory, Clinical, Product, Quality, and Data Science stakeholders.
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Identify clinical evidence gaps and recommend mitigation strategies.
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Prepare submission-ready documentation in support of CE marking activities.
Required Experience
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5+ years of experience writing CERs for medical devices under EU MDR 2017/745 .
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Demonstrated experience with Software as a Medical Device (SaMD) .
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Experience evaluating AI/ML-enabled healthcare software .
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Strong background in digital health, virtual care, rehabilitation, behavioral health, or mental health technologies.
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Proven track record developing CERs for Class IIa and/or Class IIb devices .
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Hands-on experience performing literature reviews and critical appraisal of clinical evidence.
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Experience supporting Notified Body submissions and regulatory responses.
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Experience with digital therapeutics, remote patient monitoring, or AI-driven clinical decision support tools.
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Familiarity with MEDDEV 2.7/1 Rev. 4 , MDCG guidance , ISO 14971 , IEC 62304 , and IMDRF SaMD frameworks .
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