Required skills
Languages: English
Job description
Project overview
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
Required Experience
- Author two complete CERs and supporting Clinical Evaluation Plans (CEPs) for Class IIa and Class IIb devices.
- Conduct literature searches, clinical evidence reviews, and state-of-the-art assessments.
- Evaluate clinical safety, performance, usability, and benefit-risk data.
- Assess evidence supporting AI-enabled software functionality and clinical claims.
- Collaborate with Regulatory, Clinical, Product, Quality, and Data Science stakeholders.
- Identify clinical evidence gaps and recommend mitigation strategies.
- Prepare submission-ready documentation in support of CE marking activities.
- 5+ years of experience writing CERs for medical devices under EU MDR 2017/745.
- Demonstrated experience with Software as a Medical Device (SaMD).
- Experience evaluating AI/ML-enabled healthcare software.
- Strong background in digital health, virtual care, rehabilitation, behavioral health, or mental health technologies.
- Proven track record developing CERs for Class IIa and/or Class IIb devices.
- Hands-on experience performing literature reviews and critical appraisal of clinical evidence.
- Experience supporting Notified Body submissions and regulatory responses.
- Experience with digital therapeutics, remote patient monitoring, or AI-driven clinical decision support tools.
- Familiarity with MEDDEV 2.7/1 Rev. 4, MDCG guidance, ISO 14971, IEC 62304, and IMDRF SaMD frameworks.
Project details
- Start: ASAP
- Duration: 3 months
- Remote: remote
- Location: DE
- Languages: English
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