Contract Clinical Evaluation Report (CER) Writer – SaMD, AI & Digital Health (m/w/d)

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