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 Cco, Proactive, Clo, Coo, Cro, Marketing, Domain Expertise, Dos, Willing To Relocate, Erp, Risk Management, Visio, Compliance, R&d, Financial Management, Documentation, Supervision, Budgeting

Skills Required