- Write Clinical Evaluation Plans and Reports (CEPs/CERs) and Post-market Clinical Follow-up (PMCF) Plans and Reports
- Collect, appraise and extract safety and performance data
- Compile and author new and scheduled Systematic Literature Reviews, Clinical Evaluation and PMCF documentation
- Lead CER and PMCF development by coordinating Clinical Safety, Quality Assurance, Regulatory Affairs, Clinical Affairs, research, marketing, engineering and information specialists
- Collaborate on systematic literature searches for TBCT products, equivalent, comparator and competitor products
- Review published literature for applicable safety and performance evidence
- Develop literature search strategies and facilitate SLRs
- Compile risk management, labeling, post-market surveillance, verification, validation, preclinical and clinical data
- Manage document reviews, reconcile comments and oversee final approval
- Provide input on risk management, clinical research and literature evidence for product development
- Conduct proactive literature reviews to identify complaints and safety concerns
- Represent the functional group in audits and contribute to global regulatory submissions or responses
- Monitor clinical evaluation and PMCF regulatory requirements
- Develop policies and procedures
- Guide contractors in document development and updates
- Disseminate findings from clinical evaluation and proactive literature reviews
- Develop SLR, Clinical Evaluation and PMCF deliverables, timelines and draft reviews
- Ensure compliance with applicable laws, regulations, standards and company procedures
Requirements
- Graduate degree (e.g. MS, PhD) in a scientific, biological, medical science or regulatory discipline, or equivalent education and experience sufficient to perform the essential functions
- 5 years of experience
- Knowledge of research methodology and information management
- Experience with relevant databases
- Knowledge of regulatory requirements
- Training and experience in medical writing, systematic review and clinical data appraisal
- Clinical evaluation reporting experience in academic, medical device or pharmaceutical industry clinical/regulatory roles, or device development experience
- Experience and understanding of clinical research and regulatory guidelines
- Knowledge of CE Marking, IDE, PMA, 510(k), post-market/post-approval processes, GCP procedures and legal compliance
- Proficiency with Microsoft Office, Excel, Word and PowerPoint
- Demonstrated writing and critique capability for clinical and regulatory documentation
- Program/project management skills
- Ability to develop and implement global policies and procedures
- Ability to analyze information from multiple internal and external sources
- Ability to learn general writing and presentation software
Core Competencies
Demonstrates expertise in Clinical Evaluation Plans, Post-market Clinical Follow-up documentation, and systematic literature reviews, with a strong understanding of regulatory requirements and clinical research methodologies. Proficient in managing cross-functional collaboration and ensuring compliance with industry standards and regulations.
Highest-signal resume keywords
- Clinical Evaluation Reporting
- Systematic Literature Review
- Regulatory Requirements Knowledge
- Medical Writing Experience
- Program/Project Management Skills
Hard Skills
- Clinical Evaluation Plans
- Post-market Clinical Follow-up
- Systematic Literature Reviews
- Clinical Data Appraisal
- Regulatory Guidelines
- Risk Management
- Data Analysis
- Document Development
- Clinical Research Methodology
- Compliance Standards
Soft Skills
- Collaboration
- Communication
- Critical Thinking
- Problem Solving
- Leadership
Industry Keywords
- CE Marking
- IDE
- PMA
- 510(k)
- GCP Procedures
- Post-market Surveillance
- Clinical Affairs
- Quality Assurance
- Regulatory Affairs
- Medical Device Industry
Tools & Technologies
- Microsoft Office
- Excel
- Word
- PowerPoint
- Relevant Databases
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Global Clinical Regulatory Support Specialist Arbeitgeber: Jobtailor
Als Front Office Supervisor in unserem dynamischen Team bieten wir Ihnen die Möglichkeit, in einem unterstützenden und freundlichen Arbeitsumfeld zu wachsen. Wir legen großen Wert auf die berufliche Entwicklung unserer Mitarbeiter und bieten regelmäßige Schulungen sowie die Chance, Verantwortung zu übernehmen. Unsere Lage ermöglicht es Ihnen, Teil einer lebendigen Gemeinschaft zu sein, während Sie gleichzeitig die Standards unseres Franchise-Partners einhalten und unseren Gästen einen unvergesslichen Aufenthalt bieten.
