Author and maintain high-quality clinical documents including CERs, CEPs, PMCFPs, PMCFRs, PMSP, PSURs, and SSCPs in line with EU MDR and other international standards.
Conduct thorough risk-benefit analyses and integrate data from preclinical, clinical, and post-market sources.
2. Cross-functional Collaboration:
Interface closely with R&D, Clinical Affairs, Marketing, and Regulatory teams to translate technical data into meaningful documentation.
Develop clinical and marketing communication tools such as peer-reviewed manuscripts, white papers, one-pagers, slide decks, surgical techniques, and more.
3. Scientific Literature Research & Analysis:
Design robust and reproducible literature search strategies.
Perform systematic literature reviews and create comprehensive State of the Art summaries across diverse indications and implant technologies.
4. Clinical Study Documentation:
Draft clinical trial protocols, case report forms, informed consent documents, investigator brochures, and support related regulatory submissions.
Develop and manage clinical trial documentation: site master files, trial master files, Clinical trial logs, etc.
5. Clinical Operations & Oversight:
Lead clinical budgeting and financial management, including preparation and negotiation of trial budgets, oversight of vendor contracts and clinical study agreements, and management of investigator and site payments.
Oversee aspects of clinical operations, including monitoring visits, generation of reports, and coordination with third-party CROs and sites.
Draft clinical study agreements, insurance documents, and ensure operational compliance across trial activities.
6. Regulatory & Compliance Frameworks:
Ensure documentation aligns with latest MDR 2017/745 and relevant guidance (e.g., MEDDEV 2.7.1 Rev. 4, MDCG guidelines, ISO 14155:2020, ISO 14971, etc.).
Interpret and apply risk management standards and post-market surveillance frameworks, contributing to proactive safety strategies.
Essential Requirements:
Domain Expertise:
Proven experience in authoring regulatory and clinical documents for non-active implantable medical devices.
Regulatory Acumen:
Solid understanding of relevant global regulatory frameworks, especially EU MDR, MEDDEV, MDCG guidance, and ISO/ICH standards.