Pitec Clinical

Position Overview:

We are looking for a highly skilled Medical Writer to support a leading medical device organization on a contract basis, with a primary focus on EU MDR Clinical Evaluation Reports (CERs). The successful candidate will take ownership of the development, maintenance, and updating of CERs in accordance with EU MDR requirements, ensuring robust clinical evidence to support device safety and performance. In addition to CERs, the role will contribute to other MDR clinical deliverables such as PMCF documentation and SSCPs. This position requires deep experience in clinical evaluation, strong scientific writing capabilities, and a solid understanding of regulatory expectations within the medical device sector.

Key Responsibilities:

• Lead the hands-on development, authoring, and maintenance of EU MDR–compliant Clinical Evaluation Reports (CERs).
• Independently drive end-to-end clinical evaluation activities, including clinical data identification, critical appraisal, analysis, and benefit–risk conclusions.
• Partner with Clinical Affairs, Regulatory Affairs, Quality, and R&D to obtain and interpret clinical, PMS, and PMCF evidence supporting CERs.
• Ensure CERs are scientifically robust, clearly written, and aligned with Notified Body expectations and regulatory strategy.
• Maintain CERs throughout the product lifecycle by integrating new literature, clinical investigations, PMS/PMCF results, and vigilance data.
• Author PMCF plans and evaluation reports that directly support CER updates and ongoing compliance with EU MDR.
• Develop SSCPs and supporting clinical documentation, ensuring consistency with CER conclusions.
• Perform detailed technical and quality reviews of CERs and related clinical documents to ensure regulatory compliance and submission readiness.
• Stay current with EU MDR, MDCG guidance, and evolving clinical evaluation expectations, applying updates directly to CER content and approach.

Qualifications:

Education:

• Ph.D. or M.D., in a relevant scientific or medical field (e.g., Clinical Science, Biomedical Engineering, Pharmacology, or related discipline).
• Experience:
• Minimum of 5 years of experience as a medical writer in the medical device industry, with a focus on EU MDR-related clinical documentation.
• Proven experience in writing CERs, PMCF plans/reports, SSCPs, and other regulatory clinical documents for medical devices.
• Strong knowledge of EU MDR (2017/745) and associated guidance documents (e.g., MEDDEV 2.7/1 rev 4).

Skills:

• Exceptional writing, editing, and communication skills with the ability to translate complex scientific and clinical information into clear and concise documents.
• Strong attention to detail and ability to work independently while managing multiple priorities and deadlines.
• Familiarity with clinical research methodologies, regulatory submission processes, and clinical data interpretation.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with document management systems.

Additional Desired Qualifications:

• Experience working in a cross-functional, fast-paced environment with the ability to interact effectively with regulatory affairs, clinical, and R&D teams.
• Familiarity with other international regulatory requirements (e.g., FDA, Health Canada) is a plus.
• Experience with ISO 13485, ISO 14155, and other relevant medical device industry standards.
• Ability to manage and prioritize multiple projects while ensuring quality and regulatory compliance.

Job Types: Contract

Work Location: Remote