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
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Medical Device Driver in India
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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
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.
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
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. Your Role at Baxter THIS IS WHERE you build trust to achieve results As a Lead, Sales - ITT you take pride in representing Baxter and our products. We are seeking a highly motivated and experienced Lead Sales to lead business in the North India regions, focusing on the sales of like Vest APX and other medical products. The successful candidate will be responsible for driving revenue growth, expanding market share, and building and managing the distributor network for PAN India and based out of Gurgaon. What you'll be doing Develop and implement sales strategies to achieve business objectives in the assigned regions. Conduct market research, analyze trends, and identify potential opportunities for growth for Chest wall oscillation device (vest) used in respiratory care Identify and develop new business opportunities Collaborate e
Job Title Project Manager – CAPA & Complaints Job Description Project Manager – CAPA & Complaints Your Role: Coordinate teams across Quality, R&D, Engineering, Manufacturing, Operations, Supply Chain, Procurement, Regulatory, Service and Customer Quality. Identify recurring CAPA themes and opportunities for systemic improvement. Coordinate implementation of corrective/preventive actions, including process, product, system and documentation changes. Maintain CAPA dashboards and management reporting. Drive accountability across CAPA action owners. Own and track business KPIs related to complaint and investigation timelines, quality, and throughput. Provide regular KPI, progress, and risk updates to leadership and key stakeholders. Drive timely closure of complaints and investigations through structured follow-up with action owners. You're the Right Fit If: Bachelor's or Master's degree in Mechanical/Electronics Engineering Experience: 10+ years in Project Management , preferably with CAPA and Complaints Handling in Medical Devices. Strong knowledge of Quality Management Systems and risk-management principles. Skills : Strong data analytics skills with the ability to derive insights from operational and performance data. Excellent stakeholder management and communication skills across multiple organizational levels. Strong presentation and reporting capabilities, including development of executive-level dashboards and updates. Proven ability to drive accountability and coordinate cross-functional teams without direct authority. Experience in process improvement, operational excellence, and AI
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
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 Calibration engineer Job Description Job title: Calibration Engineer Your role: The Calibration Engineer Grade 40 is involved in the in-house and outsource calibration processes, evaluating, developing, establishing and maintaining calibration methodologies, systems, and practices which meet world class standards, investigations related to the calibration process and being responsible to maintain the calibration area under control, in compliance with the applicable external standards and provide support for NPI. You're the right fit if: (4 x bullets max) 1. Experience: 5+years of industry experience in Calibration 2. Skills: Calibration Engineer will work with Philips products and processes that require calibration and/or precision controls used in the development or manufacture of Image Guided Therapy medical devices or any other medical device that require calibration. it includes support to other Philips facilities. The Engineer is mainly involved in the in-house and/or outsource calibration processes, focusing on developing, executing and documenting equipment validation (Process Characterization, Installation Qualification and Operational Qualification), process validation or requalification (Performance qualification). Responsible for developing the calibration specifications for various equipment used by Philips facilities and staff. Development of calibration procedures and methods to support specifications, blueprints, drawings, and other technical requirements. Coordinate with internal customers and external service providers Be part of the problem-solving process if difficulties arise as part of the calibration process, it includes investigations like OOT, NCR and CAPA Maintain, review, and revise quality standards and help with development and redesign as
Job Title Design Quality Engineer Job Description Job title: Design Quality Engineer You Role: While positioned within the Business Unit MR, reporting to the Segment OEM & Coils DQE Leader, you will support the Quality, Reliability and Safety of Medical Devices though all lifecycle phases of the medical device. You will contribute to achieve quality objectives as they relate to: Customer Experience, Complaint Rate, and First Past Yield. You will work in an independent Quality & Regulatory organization with key stakeholders during various stages of the design, development and maintenance of the medical device. Representing Design Quality during the execution of new development programs and sustaining activities and interfacing with regulatory affairs Independent oversight of product performance as this relates to Product Quality, Safety and Reliability During (early) Development and Lifecycle Maintenance: Participate in establishing the quality and reliability strategy specific to the product(s) in scope. Involved in quality target setting in Project Charter Act as a product quality lead by defining the activities in the Product Quality Plan to meet product quality targets Contribute to the execution and delivery of results specific to product quality: Review reliability plans , review key quality related requirements , ensure a proper transfer of design specifications to manufacturing and supply chain and service, perform assessment on the design/architecture on suitability for the quality criteria, and review key product related deliverables (Reliability Reports, Reliability modelling for predictive analysis, FMEA’s, Change Point Analysis, etc.) Apply and facilitate Design for Quality & Reliability best practices (FMEAs, ro
Work Flexibility: Field-based Key Account Manager: As an Individual contributor position this role is pivotal in unifying all the elements of successful Accounts Management & New projects that will not only strengthen relationship but also unlock untapped value for both – Stryker and our Key Accounts. This position will champion the Customer’s voice within Stryker while simultaneously advocating a Solution Centric approach within the Key Account, built around strategic offering of Stryker’s portfolio. The basic expectation from this position is to strengthen existing relations and to establish new relationships in newly acquired accounts while insulating these accounts from competition. This position focuses on Long Term gain and strives to maximize business opportunity within the Key Accounts. New upcoming hospital Project support, execution, and delivery of medical device projects. The role involves gathering customer requirements, coordinating cross-functional teams, ensuring regulatory compliance, managing project documentation, and supporting product implementation from project initiation through customer handover. What You Need: Bachelor’s degree with strong academic credentials, complemented by an MBA from a reputed business school. 8-10 years of professional experience, with a proven track record of driving business growth and delivering results in a dynamic environment. Strong relationship-building skills with the ability to establish trust, influence stakeholders, and maintain effective internal and external partnerships. Demonstrated program and project management capabilities, including analytical thinking, prioritization, and execution excellence in cross-functional settings. Strategi
Job Title Site Leader (Director), Operations Quality Assurance- Job Description The Site Leader (Director), Operations Quality Assurance is responsible for leading the Quality function across the Pune (Chakan) manufacturing sites. This role provides strategic and operational leadership to ensure all medical devices, manufacturing processes, and quality system activities comply with applicable regulatory requirements, Philips standards, and business objectives. Your Role: Lead all Operations Quality Assurance activities across the Pune (Chakan) manufacturing sites, ensuring compliance, product quality, patient safety, and operations quality performance. Accountable for developing and executing the Operations Quality Strategy, translating enterprise quality objectives into measurable site-level priorities/results, driving a culture of quality and compliance, ensuring inspection readiness, and continuously improving quality performance across the sites. As the senior Quality leader and designated Quality Management Representative, the Director represents the organization during regulatory inspections/external audits, ensures the effectiveness and compliance of the Quality Management System and partners closely with Operations, R&D, Regulatory Affairs, Supply Chain, and Business Leadership to ensure product quality, patient safety, and business continuity. Ensure all products, manufacturing processes, and quality system activities comply with FDA regulations, ISO 13485, ISO 14971, MDSAP, EU MDR, and other applicable global requirements. Lead and represent the sites during FDA inspections, Notified Body audits, customer audits, and regulatory authority interactions, maintaining a continuous state of inspection readiness. Drive timely resolution of audit findings, compliance gaps, nonconformances, and CAPA act
Work Flexibility: Hybrid What you will do: • Under minimal supervision, research, design, develop, modify, and verify components/modules for medical devices; translate design inputs to engineering specifications and produce sub-system level designs and develop and analyze solutions, prototyping one or more options to provide proof of concept. • Apply fundamental and some advanced concepts, practices and procedures for problem solving • Demonstrate advanced understanding of customer needs and design inputs; proficiency with product’s intended use and clinical procedures and learn how the financial models are constructed • Follow fundamental industry standards, design requirements and test strategies which apply to regulatory requirements • Independently create or refine engineering documentation, such as the Design History file and follow R&D procedure like design controls and risk management, per the Quality Management System • Under minimal supervision, work with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success • Quickly process and assimilate procedures, policies, processes, systems, and technology required and work on complex problems, applying advanced experience and learnings • Demonstrate ownership and prioritize work with minimal supervision and works as key member of the team, collaborating with others and solidifying relationships Required Qualifications : Bachelor of Science in Engineering, Mechanical Engineering or BioMedical & 2+ years of work experience Experience- 4.5 years- 7 years CAD expertise Conceptual knowledge(basics should be clear); Manufacturing drawing; Mechanical Design; GD&T Preferred Qualifications : Working knowledge and under
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Endo Mechanical and Intelligent Devices (EMID) provides a broad portfolio of surgical technologies, including open and laparoscopic stapling systems, ligation devices, access and hand instruments, powered stapling platforms, and intelligent surgical solutions that support procedural efficiency and clinical outcomes. The team partners with surgeons, operating theatre staff, and healthcare institutions to expand adoption of advanced surgical technologies across assigned territories. This role is based in Mumbai, India and is field-based/onsite within the assigned territory. The Territory Manager will be responsible for driving business across government hospitals in Mumbai and is expected to travel regularly within the city to support customer engagement, operating theatre coverage, product evaluations, training, and account development activities. The Territory Manager is responsible for driving sales growth, market development, and customer engagement for the EMID portfolio across government hospitals in Mumbai. This role works closely with surgeons, operating theatre teams, procurement stakeholders, and key opinion leaders to support product adoption, deliver clinical and technical expertise, and achieve territory business objectives. Responsibilities may include the following and other duties may be assigned: Achieve territory sales objectives by driving product adoption, utilisation,
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