Functional Consultant - Medical Device Regulatory Affairs and RWE

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Functional Consultant Life Sciences

Decision Sciences Lifecycle

Domain Expertise

at least one

Regulatory Data Management & Analytics

• Proficient in managing regulatory data lifecyclesfrom data collection and validation to statistical analysis and reporting, with a focus on RWE generation from sources like electronic health records (EHR), claims data, registries, and post-market surveillance systems
• Experience with standards such as CDISC (where applicable), ISO 14155, and tools like SAS, R, or Python for handling device performance and safety data
• Understanding of regulatory compliance (e.g., FDA 21 CFR Part 11, EU MDR/IVDR) and post-market surveillance data requirements
• Familiarity with clinical evaluation design, including risk-based monitoring, endpoint analysis, and integration of RWE for regulatory decision-making
• Knowledge of real-world evidence (RWE) integration and post-market surveillance data analytics, including leveraging real-world data for label expansions, safety assessments, or conformity assessments
• Proficiency in monitoring and analyzing adverse event data, signal detection, and risk management planning using databases like MAUDE, EudraVigilance, or internal vigilance systems
• Experience with vigilance systems for medical device reporting and safety database management
• Familiarity with post-marketing studies, including Post-Market Clinical Follow-up (PMCF) under EU MDR, and compliance with global regulatory requirements for RWE

Medical Device Regulatory Affairs Process

• Expertise in overseeing end-to-end regulatory workflows, from design controls through pre-market submissions to post-market compliance, with emphasis on evidence-based submissions supported by RWE
• Experience in integrating cross-functional inputs from quality, clinical, engineering, and manufacturing teams to streamline regulatory timelines
• Knowledge of Quality Management Systems (QMS) processes, including design controls (21 CFR 820), risk management (ISO 14971), and human factors/usability engineering
• Familiarity with translational activities, bridging non-clinical testing to clinical evaluation and regulatory strategy using RWE
• Proficiency in risk assessment and mitigation strategies for device development, including managing critical path activities and ensuring regulatory readiness
• Expertise in navigating regulatory submission processes for 510(k), PMA, IDE, De Novo, Technical Documentation under EU MDR/IVDR, or equivalent filings with FDA, Notified Bodies, or PMDA
• Experience in preparing and reviewing regulatory documentation, including technical files, design dossiers, clinical evaluation reports (CER), post-market surveillance plans, and vigilance reports
• Knowledge of global regulatory guidelines (e.g., ISO 13485, MDR/IVDR, IMDRF) and their application to the medical device lifecycle
• Hands-on experience in usability testing, biocompatibility assessments, or performance evaluation of devices
• Knowledge of device classification, sterilization validation, cybersecurity, and software as a medical device (SaMD) considerations
• Familiarity with regulatory intelligence analytics and using RWE to strengthen submissions or respond to regulatory queries

Additional Competencies

Additional competencies in data science and analytics using R, Python, or SQL, along with familiarity with Agile methodologies, JIRA, and other project management tools, are considered strong advantages. Experience with AI/ML tools, data visualization platforms (e.g., Tableau, Power BI), and working in cross-disciplinary environments will be a plus.