Medical & Regulatory Writer

Role Overview: Lead clinical and regulatory documentation and clinical evidence generation for non-active implantable medical devices. Responsible for authoring EU MDR–compliant clinical documents and supporting the design, execution, and oversight of pre- and post-market clinical studies. Key Responsibilities: Author and maintain CER, CEP, PMCF, PMS, PSUR, and SSCP documentation as per EU MDR. Conduct literature reviews, risk–benefit analyses, and state-of-the-art assessments. Draft clinical protocols, study reports, and regulatory submission documents. Support and oversee clinical study operations, vendors, and CROs. Collaborate cross-functionally to support regulatory compliance and evidence strategy. Key Skills & Knowledge: Strong expertise in EU MDR, MEDDEV, MDCG, ISO 14155, ISO 14971, ICH-GCP, and NDCT-2019. Proven experience in clinical and regulatory writing for implantable medical devices. Excellent scientific writing, analytical, and stakeholder communication skills . Skillset Required: Cco, Proactive, Clo, Coo, Cro, Marketing, Domain Expertise, Dos, Willing To Relocate, Erp, Risk Management, Visio, Compliance, R&d, Financial Management, Documentation, Supervision, Budgeting