309 Iso 13485 Jobs

We are currently seeking an experienced Global Regulatory Program Manager to help manage a new internal initiative within Oracle Health.In this critical role, you will help drive definition and clarity around customer excellence, specifically focusing on leveraging regulatory knowledge and technical expertise to ensure Oracle Health compliance is met on documentation required for conformity on all Oracle Health products deemed a medical device. The outcomes of this role are to define, measure, and hold Oracle Health product teams accountable to the newly defined operational bar established for global regulatory technical compliance. You will be specificallyresponsible for the successful mana...

We are currently seeking an experienced Global Regulatory Program Manager to help manage a new internal initiative within Oracle Health.In this critical role, you will help drive definition and clarity around customer excellence, specifically focusing on leveraging regulatory knowledge and technical expertise to ensure Oracle Health compliance is met on documentation required for conformity on all Oracle Health products deemed a medical device. The outcomes of this role are to define, measure, and hold Oracle Health product teams accountable to the newly defined operational bar established for global regulatory technical compliance. You will be specificallyresponsible for the successful mana...

Job Description Job Title : QMS and MS Manager Job Responsibilities: Takes ownership of the Document and Change Control activities and training activities for the Personal Health Management System Supports the Document and Change Control activities of the Personal Health Quality Management System by contributing to the development, implementation, and revision of MS-QMS processes, including standard operating procedures (SOPs) and work instructions, ensuring their accuracy, clarity, and compliance with relevant standards. Leads and or supports PH Regions and PH CoE's QMS relevant activities and projects. Responsible for the translation of Management System and Quality Management System conte...

As a Product Manager at mlHealth 360 , you will lead the next phase of development for our AI-driven Radiology solutions, including medical imaging diagnostic AI products. The ideal candidate will combine technical acumen, clinical understanding, and regulatory awareness to drive end-to-end product lifecycle from concept to deployment and compliance with Indian SaMD regulations. Key Responsibilities 1. Product Strategy & Roadmap Define and own the product roadmap for AI-based radiology applications in CT, MRI, and X-ray domains. Conduct market and competitive analysis to identify gaps, unmet clinical needs, and differentiation opportunities. Collaborate with leadership to align product goals...

Job Title QMS and MS Manager Job Description Job Title : QMS and MS Manager Job Responsibilities: Takes ownership of the Document and Change Control activities and training activities for the Personal Health Management System Supports the Document and Change Control activities of the Personal Health Quality Management System by contributing to the development, implementation, and revision of MS-QMS processes, including standard operating procedures (SOPs) and work instructions, ensuring their accuracy, clarity, and compliance with relevant standards. Leads and or supports PH Regions and PH CoE's QMS relevant activities and projects. Responsible for the translation of Management System and Qu...

Technical Writer (Medical Devices) Intern Location: Chennai IIT Madras Research Park (Onsite) Employment: Contract (6 months) with option to extend or convert to full?time Start: Immediate Salary: 10,000 per month Why this role Floaid is finalizing documentation for a new platform. We need a hands?on technical writer who can rapidly bring our User/Operator Manual , Service & Maintenance Manual , Installation & Commissioning Guide , and related controlled documents to release quality under a medical?device QMS. What you'll own (deliverables) Operator Manual (IFU): setup, priming, alarms, operating modes, UI walkthroughs, cleaning/sterilization, warnings/contraindications, symbol glossary (ISO...

Company Description Royal Surgicare Pvt. Ltd. is a trusted manufacturer and exporter of quality medical consumables, based in Santej(Gujarat, India). We offer a wide range of products for Infusion Therapy, Transfusion Therapy, Gastroenterology, Urology, Anesthesia, and General surgery. Our facility operates under ISO 13485: 2016 standards to ensure consistent product quality. We are committed to delivering reliable and precise medical solutions. Role Description Oversee all Quality Assurance and Quality Control activities to ensure product safety, quality, and compliance. Ensure adherence to ISO 13485, EUMDR and applicable regulatory requirements. Review and approve quality documents, SOPs, ...

Experience in Manual system testing (Experience in Medical device testing is a plus point). Understand, develop and execute verification test methods, protocols, and reports for verification. Design test cases to include test methodology, test setups, materials, equipment, procedure, and acceptance criteria by analyzing requirements. Hands on experience in End to End test process. Experience in functional testing Develop and maintain the testing artifacts as per QMS requirements. Hands on experience in regression testing and defect reporting / tracking. Good knowledge on Medical device standards like ISO 13485, ISO 14971, FDA, CE and IEC standards. Working experience on tools like JAMA, JIRA...

Job Title: Senior Trainer Validation (CQV, Equipment, Injection Mold, HVAC) Location: Remote Job type: Part-time Job Summary: To design, develop, and deliver comprehensive training programs on Commissioning, Qualification & Validation (CQV), Equipment Qualification, Injection Molding Process Validation, and HVAC System Validation. The trainer will ensure technical competency development across engineering and quality teams in compliance with international regulatory standards (USFDA, EU GMP, ISO 13485, etc.). Key Responsibilities: Develop and deliver training modules on: Commissioning, Qualification, and Validation (CQV) lifecycle Equipment Qualification (IQ/OQ/PQ) Process Validation for Inj...

About Us We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence. As a trusted voice for many of the world's most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations. About SCPA We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance ind...

Tips: Provide a summary of the role, what success in the position looks like, and how this role fits into the organization overall. Responsibilities Participate in the implementation and maintenance of the management system compliance with relevant international quality standards and regulatory requirements (Such as ISO 13485, ISO 14971, MDR 2017/745, and 21 CFR part 820). Participate in development of Regulatory Strategy for upcoming products against GSPR requirements. Participate in the development of QA strategies, recommendations for Continual improvement, Quality planning in conjunction with the needs of the company, for each product range and Quality Management System. Sustain and acti...

Define and implement reliability strategies and frameworks for software systems. Collaborate with cross-functional teams to integrate quality and reliability engineering throughout the SDLC. Lead risk management activities including DFMEA, hazard analysis, and traceability. Design and maintain post-market monitoring and alerting solutions to proactively address issues. Conduct root cause analysis and drive effective CAPA implementation. Develop tools and automation for reliability testing and validation. Ensure system availability through redundancy, failover, and recovery strategies. Support audits, regulatory inspections, and compliance with IEC 62304, ISO 13485, and ISO 14971. Mentor team...

We are seeking a highly experienced Senior Data Scientist to join our Digital Team for Infusion Pumps product. As a Senior Data Scientist, you will play a critical role in developing and deploying AI/ML models that calculate clinical limits for infusion therapy executed with Infusion Pumps based on historical data of previous infusions. Your expertise in data science, machine learning, and software development will help us improve the accuracy and reliability of our product, ultimately enhancing patient care. Key Responsibilities: AI/ML Model Development Develop and deploy AI/ML models that calculate clinical limits for infusion therapy executed with Infusion Pumps based on historical data o...

Key Responsibilities: Develop and maintain a Software Verification Plan (SVP) per IEC 62304, ensuring coverage of all required activities (unit, integration, system, acceptance). Align verification activities with the organization's Quality Management System (QMS) as required by ISO 13485, ensuring all SOPs, templates, and records are used and maintained. Establish and maintain traceability between software requirements, risk controls, and verification tests. Oversee creation and peer review of verification protocols, test cases, test scripts, and test data, ensuring direct traceability to software/system requirements and risk mitigations. Ensure objective evidence (test records, logs, scree...

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. ...

Responsibilities: * Ensure compliance with regulatory requirements for medicaldevices * Oversee radiation safety protocols and training programs * Manage licensing processes for medical devices * M.Sc(Medical Physics, Radiation Physics, Life sci eng.

Develop and maintain V&V strategy, plans, and protocols for ventilator systems in compliance with regulatory and quality standards. Define test methodologies for system-level, subsystem-level

Dear Candidates, Hiring For Top MNC Company Role : Embedded Device Manual Software Verification Location : Chennai & Bangalore Experience : 5+ Years of experience Notice Period : Immediate to 30 days Note : Walkin Drive on 25th Oct-25 Only one of interview and offer letter will be issued on the same day 5 + years of experience in Embedded Device Manual Software Verification Expertise in understanding the System and Software architecture, Test protocols, debugging and test execution. Basic Embedded C coding skills, understanding the design is essential( 50% C programming skills required or trainable) Experience in Test protocol design , review and update Hands-on work experience in communicat...

A Day in the Life Sr Design Quality Engineer role for ENT Responsibilities may include the following and other duties may be assigned Review new and modified product design documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements. Ensure that product development projects and changes to existing products are conducted in compliance with FDA Quality System Regulations, EU MDR and inhouse Standards. Participate on cross-functional teams to develop product risk management file (risk management plan, Hazard Analysis, DFMEA, and risk management report) as per ISO 14971. Familiar with ISO 9001, ISO 13485, ISO 14971, I...

The Head of Regulatory Affairs will lead the regulatory function for Healthineers, Zone India, ensuring compliance with national and international regulations while supporting the company's strategic objectives. This role requires an experienced leader who can navigate the dynamic regulatory environment, advocate for the company's interests, and enable the successful registration, approval, and lifecycle management of medical devices in the Indian market. The individual will act as the primary point of contact with regulatory authorities, including the Central Drugs Standard Control Organization (CDSCO), and drive cross-functional collaboration to align business goals with regulatory require...

We are looking at Candidates who has exposure to the following : EHS compliance , hands on experience in handling ETP, PCB with 8 to 10 years work experience. Pollution Prevention Statutory Compliances Wastewater Treatment Job Description Position: Associate Manager EHS position Reports to: General Manager Dotted Line Reporting : Senior Manager Human Resources Location: Jigani, Bangalore, India Languages: English, Hindi, Kannada speaking (Preferable) Job Responsibilities Ensuring Safe and Healthy environment in the entire workplace. Co-ordination with external auditing agencies related to Safety, Health and Environment. Coordinate and foster continuous improvement of day-to-day Environmental...

Plan and execute production based on indents from Domestic, Tender and International Business. Coordinate with PPC and Purchase teams to achieve targets by maintaining appropriate inventory at in-process and raw material stores. Oversee production processes for Sutures, Mesh, Clinicel, Skin Stapler, Umbilical Cotton Tape, Endo Surgery products, Kits, Truloop, Wax, Arthroscopy, new products, samples and new codes. Collaborate with Sales and Marketing teams to ensure timely delivery and achieve organizational goals. Ensure production execution aligns with the approved plan and drive overall production realization. Actively contribute to corporate projects on innovation, cost savings, new produ...

Assistant Manager / Manager - R&D | NPD | 6 - 8 Years | Coimbatore Roles & Responsibilities Drive New Product Development (NPD) projects through the stage-gate process, including design inputs, prototyping, verification & validation, pilot builds and product launch. Manage documentation including design history files, test reports, change control and regulatory submissions. Conduct microbiology tests, validation studies and risk management activities such as DFMEA and hazard analysis. Engage and collaborate with suppliers for material selection, qualification and audits. Track project timelines, budgets and performance metrics, ensuring adherence to quality and regulatory standards. Ensure c...

About Us: Adiuvo Diagnostics is a deep-tech medical technology company developing next-generation diagnostic platforms that integrate optics, electronics, and artificial intelligence to enable rapid, non-invasive detection of infections at the point of care. Our interdisciplinary team brings together expertise in engineering, biology, and computational sciences to transform diagnostics globally. Role Summary: We are looking for a hands-on R&D leader to drive the research, design, and development of Adiuvo's diagnostic technologies. The role demands a balance between technical depth and practical product realization someone who can architect systems, mentor engineers, and personally contribut...

Title: Senior Platform Manager (Enterprise SaaS) Location: In Office, Bangalore Type: Full-Time The Role We re looking for a Platform Manager who can bring structure to chaos. You ll be defining the specs, juggling two customer-facing co-founders to get alignment on what gets built with a clear why. You ll ensure everything in the backlog is well-groomed, technically feasible, and mapped to real customer pain points as seen by different teams so that engineers can build fast and correctly the first time. The negative KR is the number of releases by the engineering team that get stuck in the beta environment because of a lack of stakeholder alignment. This means you ll do a bit of everything:...