Global Clinical Regulatory Support Specialist

Jobtailor; Deutschland; Remote; EUR 90.000 - 110.000; Vollzeit

Zusammenfassung

Jobtailor is seeking an experienced professional to lead Clinical Evaluation and PMCF efforts in a regulated medical device context. You will author CEPs/CERs, plan PMCF activities, and coordinate safety data collection and literature reviews across multiple disciplines.

The ideal candidate holds a graduate degree in a scientific or regulatory field and has at least five years of experience in regulatory writing, literature appraisal, and clinical data analysis.

Qualifikationen

• Graduate degree in a scientific, biological, medical science or regulatory discipline.
• 5 years of experience in related roles.
• Knowledge of research methodology and information management.
• Experience with regulatory requirements.
• Training and experience in medical writing, systematic review and clinical data appraisal.
• Clinical evaluation reporting in academic, medical device or pharmaceutical industry roles.

Aufgaben

• Write Clinical Evaluation Plans (CEPs) and Reports (CERs) and PMCF Plans/Reports.
• Collect, appraise and extract safety and performance data.
• Compile and author Systematic Literature Reviews and PMCF documentation.
• Lead CER and PMCF development by coordinating Clinical Safety, QA, RA, and research teams.
• Collaborate on systematic literature searches for TBCT products and equivalents.
• Review published literature for safety and performance evidence.
• Develop literature search strategies and facilitate SLRs.
• Compile risk management, labeling, post-market surveillance and data.
• Manage document reviews and oversee final approvals.
• Provide input on risk management and literature evidence for product development.
• Conduct proactive literature reviews to identify complaints and safety concerns.
• Represent the function in audits and regulatory submissions/responses.
• Monitor regulatory requirements for CER and PMCF.
• Develop policies and procedures; guide contractors in doc development and updates.

Kenntnisse

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

Ausbildung

Graduate degree in scientific/biomedical/regulatory discipline

Tools

Microsoft Office

Excel

Word

PowerPoint

Relevant Databases

Jobbeschreibung

• 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