Functional Consultant

Job Title: Functional Consultant - Medical Device Regulatory Affairs and RWE Experience: 6–10 years Industry: Pharmaceutical / Biotechnology Location: Bangalore Employment Type: Full-Time Our client – one of the largest data science companies – is seeking to hire a Functional Consultant – Life Sciences with 6–10 years of experience in the medical device industry, specifically within regulatory affairs and compliance, with a preference for hands-on involvement in Real World Evidence (RWE) generation for regulatory bodies such as FDA or under EU MDR. The ideal candidate will have a strong foundation in managing RWE studies which are for regulatory affairs stakeholders, coordinating cross-functional teams, and collaborating with global stakeholders across geographies. Demonstrated experience in project execution, scientific communication, and data-driven decision-making is essential. The ideal candidate will embrace the Company’s Decision Sciences Lifecycle and ways of working, acting as a strategic transformation partner to drive long-term business, financial, and operational outcomes. They will leverage advanced analytics, machine learning, statistical modeling, and a global delivery model to build data-driven solutions. The role involves shaping growth strategies, identifying new business opportunities, and applying design thinking for structured problem-solving. Candidates should deliver actionable insights through compelling data visualizations, reports, and presentations, while also monitoring solution performance and ensuring continuous optimization. Leadership of offshore teams, including onboarding, mentoring, and performance management, is a key responsibility. Domain Expertise Candidates must have hands-on experience or exposure to at least one of the following functional domains: Regulatory Data Management & Analytics Proficient in managing regulatory data lifecycles—from 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.