Job Description

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

Skills Required