Functional Consultant - Medical Device Regulatory Affairs and RWE

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

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.