Medical Reviewer Consultant in Bengaluru

Job Title NPSS Quality Assurance Manager Job Description Job Title: NPSS Quality Assurance Manager Lead and execute compliant, risk-based assurance for computerized systems that support medical device quality and business processes. This role combines hands-on Computer System Validation (CSV), quality oversight, stakeholder leadership, and audit readiness across the system lifecycle. Focus CSV / CSA and Quality Assurance Experience 8+ years in regulated environments Work Model Office-based / Hybrid designation to be confirmed The opportunity As an NPSS QA Manager, you will own and strengthen the validation and assurance framework for non-product software and computerized systems used in a regulated medical device environment. You will partner with process owners, IT, Quality, Regulatory, Cybersecurity, Privacy, suppliers, and project teams to ensure systems are fit for intended use, compliant, inspection-ready, and maintained in a validated state. Your role Provide quality oversight and consultancy across the full computerized system lifecycle, including intended use, classification, validation planning, requirements, risk assessment, supplier assessment, test strategy, traceability, release, change control, periodic review, incident and problem management, and retirement. Develop, implement, and maintain computerized system validation deliverables, procedures, and guidance for CSV and Computer Software Assurance (CSA). Collaborate effectively with project teams and the NPSS team, consistently applying current GxP standards. Apply a risk-based, critical-thinking approach that scales assurance activities to patient safety, product qual

Job Title NPSS Quality Assurance Manager Job Description Job Title: NPSS Quality Assurance Manager Lead and execute compliant, risk-based assurance for computerized systems that support medical device quality and business processes. This role combines hands-on Computer System Validation (CSV), quality oversight, stakeholder leadership, and audit readiness across the system lifecycle. Focus CSV / CSA and Quality Assurance Experience 8+ years in regulated environments Work Model Office-based / Hybrid designation to be confirmed The opportunity As an NPSS QA Manager, you will own and strengthen the validation and assurance framework for non-product software and computerized systems used in a regulated medical device environment. You will partner with process owners, IT, Quality, Regulatory, Cybersecurity, Privacy, suppliers, and project teams to ensure systems are fit for intended use, compliant, inspection-ready, and maintained in a validated state. Your role Provide quality oversight and consultancy across the full computerized system lifecycle, including intended use, classification, validation planning, requirements, risk assessment, supplier assessment, test strategy, traceability, release, change control, periodic review, incident and problem management, and retirement. Develop, implement, and maintain computerized system validation deliverables, procedures, and guidance for CSV and Computer Software Assurance (CSA). Collaborate effectively with project teams and the NPSS team, consistently applying current GxP standards. Apply a risk-based, critical-thinking approach that scales assurance activities to patient safety, product qual

Job Title: Lead - Aggregate Reporting Employment Type: Full-time Work Type: Remote About ClinChoice: ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis. Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, the United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally. We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision. Primary Responsibilities: Responsible for authoring Aggregate Safety Reports (including but not limited to PBRER/PSUR, ACO, DSUR, PADER, CAR, RMP, Ad-hoc safety reports for medicinal and non-medicinal products and EU-MDR PSUR, PMSR, PMSP, and PRER reports for medical devices, and Cosmetovigilance reports for Cosmetic products for submissions to various health authorities as per the requirement). Plan report-specific timelines, identify relevant stakeholders, request calls for contributions, and coordinate with various stakeholders for obtaining relevant data for the preparation of aggregate safety reports. Review the safety data (including the seriousness and expectedness assessments of events, as may be necessary) as per the agreed strategy and sponsor’s conventions and verify the correctness and completeness of contributions received from stakeholders. Perform aggregate review of post-marketing cases received in global databases and assess whether the cases alter t

Job Title Process Engineer Job Description Job title: Process Engineer Your role: Seeking a senior Process Engineer to lead process governance, compliance, and operational excellence initiatives within Digital Innovation Platforms. This individual will act as a process leader across engineering, operations, cybersecurity, and quality organizations, ensuring scalable and compliant ways of working while driving continuous improvement and business transformation. experience in Process Engineering, Quality Systems, Operational Excellence, or Compliance roles. Experience working in regulated software, cloud, digital health, medical device, healthcare technology, or similar environments. Strong knowledge of ISO 9001, ISO 27001, ISO 27018, HIPAA, HiTrust, CAPA, and quality system processes. Experience leading cross-functional initiatives involving engineering, operations, cybersecurity, and quality stakeholders. Strong process mapping, root cause analysis, change management, and continuous improvement skills. Experience supporting audits, compliance programs, ISMS activities, and regulatory inspections. Excellent communication, stakeholder management, and executive presentation skills. Ability to influence without direct authority and drive adoption across global teams. Independently leads larger and more complex initiatives. Influences multiple organizations and senior stakeholders. Owns strategic process governance programs. Drives enterprise-wide process improvements. Serves as a subject matter expert and mentor. Demonstrates greater autonomy, business impact, and leadership responsibility. You're

Job Title: Assistant – Operations Employment Type: Contract (12 months) Location: Bengaluru, India Work Type: Office-based Experience: 1–1.5 years About ClinChoice ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis. Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, the United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally. We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision. Primary Responsibilities • Biometric & Access Management: Manage biometric attendance systems and employee access control. Activate access for new joiners and deactivate access for exiting employees. Coordinate maintenance and troubleshooting of biometric devices. Maintain and update biometric and access trackers. • CCTV Monitoring & Maintenance: Monitor CCTV systems and ensure proper functioning. Maintain CCTV time synchronization and recording accuracy. Coordinate with vendors/service providers for maintenance and issue resolution. • Security & Housekeeping Coordination: Supervise security and housekeeping operations. Manage attendance and manpower allocation for security/HK staff. Ensure workplace cleanliness, safety, and operation

Title: Senior AI QA Engineer Location: Bengaluru (Bangalore) Opportunity: As a Senior AI QA Engineer for our Precision Patient Care Pipeline , you will go beyond traditional functional testing. You will be responsible for building the framework that ensures our clinical insights are accurate, safe, and reliable. This role requires a unique blend of high-level software testing and data engineering to validate complex, non-deterministic medical outputs using a hybrid of automated grading methodologies . Key Responsibilities: Architect Multi-Layered Validation Frameworks: Design and implement structured testing strategies that combine deterministic checks, semantic similarity metrics, and model-based evaluations. Automated Model Grading: Develop systems to evaluate clinical pipeline outputs for faithfulness, safety, and hallucination detection using various automated scoring techniques (e.g., BERTScore, ROUGE, or custom heuristics). Vibe-Driven Development: Leverage agentic AI tools to rapidly prototype complex test harnesses, "red-team" clinical logic, and build internal validation utilities at high velocity. Data Pipeline Integrity: Execute integration and regression tests for data-heavy backend processes, ensuring medical data remains consistent from ingestion to insight generation. Collaborative Strategy: Work closely with Data Scientists and Product Managers to define "Ground Truth" datasets and clinical evaluation rubrics. Root Cause Analysis: Deep-dive into complex system failures to identify whether issues stem from code logic, data drift, or model behavior. Requirements: 6+ years of technical experience in Quality Assurance, with a strong focus on system architecture and backend data validation. Advanced Python Proficiency: Expert-level skills in Python for building custom test scripts and working within AI/ML ecosystems. AI/ML Validation Experience: Proven experience testing model outputs using diverse metrics (e.g., Semantic Similarity, NLP metrics, an

Job Title Lead Software Technologist I - UI Job Description Minimum required Education: Bachelor's / Master's Degree in Computer Science, Software Engineering, Information Technology or equivalent. Job title: Lead Software Technologist I Your role: Lead development of intuitive clinical user interface applications used by clinicians in high-acuity environments. Collaborate with UX teams and clinicians to ensure applications meet usability and safety requirements. Provide technical leadership across modern UI technologies and supporting C++ layers for embedded devices. Lead and mentor Platform development teams on software architecture, design patterns, and embedded systems best practices through daily hands-on collaboration. Lead and mentor application development teams on application services for physiological data visualization, and clinical decision support features. Establish and enforce quality standards, development methodologies, and coding practices that drive continuous improvement in software reliability and performance. Conduct rigorous code reviews and provide constructive technical feedback to ensure adherence to medical device software standards (IEC 62304, FDA regulations) Optimize application performance by identifying and resolving bottlenecks in resource-constrained embedded Linux environments. Drive the adoption of AI-enabled development tools and demonstrate measurable productivity improvements across the team. Collaborating with cross-functional teams including Product Management, QA, Regulatory, and other engineering leads to define and deliver features. Support software lifecycle management activities including sustaining engineering, defect resolution, and platform evolution.

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Job Description Your Role at Baxter This is where your work saves lives. As a Principal Product Cybersecurity Engineer, you will own and direct the cybersecurity design, architecture, and analysis of medical devices, digital platforms, and connected healthcare solutions. You will serve as a cybersecurity subject matter expert, leading security initiatives from concept through deployment while providing technical leadership and mentorship across cross-functional teams. You will drive cybersecurity strategy, influence technical decision making, and ensure prod

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Job Description Essential Duties and Responsibilities The Associate Marketing Manager, Global Marketing – Access is responsible for driving global marketing strategy and execution across the full product lifecycle for the Access portfolio. This role serves as the primary commercial representative for new product development (NPD), sustaining project organization (SPO) initiatives, and in‑market optimization, working cross‑functionally with R&D, Regulatory Affairs, Medical, Quality, Supply Chain, Finance, and regional marketing teams. This role is an individual contributor with significant influ