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,...