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