7 Iec 62366 Jobs

About OptraSCAN: We are a fast-growing health-tech company focused on building AI-enabled digital pathology solutions that are used by hospitals, laboratories, CROs, and pharma companies in over 30 countries. Our mission is to make precision diagnostics more accessible, efficient, and intelligent. With OptraSCAN , transitioning from conventional microscopy to digital pathology becomes seamless. Our solutions enable effective acquisition of whole slide images, along with features such as viewing, storing, archiving, real-time sharing, and reporting. We offer various pricing models to suit your specific needs and budget. Job Description: OptraSCAN is seeking a highly detail-oriented and knowledgeable Regulatory Specialist Technical Writer to create, manage, and maintain regulatory documentation required for product approvals, certifications, and market access in global markets. This role involves a combination of regulatory strategy and high-quality technical writing for medical devices (hardware and software), with a focus on ensuring compliance with international standards such as ISO 13485, FDA 21 CFR Part 820, EU MDR, and others. Note: - Apply only if you have experience in IEC 62304 ,IEC 62366, IEC 60601, ISO 14971. Key Responsibilities: Regulatory Documentation & Submissions. Prepare and maintain high-quality regulatory documentation including: Technical Files / Design Dossiers Clinical Evaluation Reports (CERs) Risk Management Files Declarations of Conformity FDA submissions (510(k) or pre-submissions, if applicable) Collaborate with cross-functional teams to gather inputs from R&D, QA, Clinical, and Marketing for submission documents. Technical Writing: Write, edit, and proofread SOPs, work instructions, user manuals, labeling, and IFUs to ensure technical accuracy and regulatory compliance. Translate complex technical data into clear, concise, and user-friendly documentation. Compliance & Standards: Stay current with regulatory changes (EU MDR, FDA, etc.) and update internal documentation and processes accordingly. Ensure documentation aligns with applicable standards such as: ISO 13485 ISO 14971 (Risk Management) IEC 62304 (Software Lifecycle) IEC 62366 IEC 60601 (Electrical Medical Devices) EU MDR 2017/745 FDA 21 CFR Part 820 Quality System Support: Support internal audits and inspections by maintaining complete and audit-ready documentation. Assist in CAPA documentation and post-market surveillance reports when required. Required Qualifications: Bachelors or masters degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field. 25 years of experience in regulatory writing or regulatory affairs in a medical device or healthcare product environment. Strong knowledge of global medical device regulatory frameworks (FDA, EU MDR, etc.). Excellent written English and technical writing skills. Strong organizational and project management skills. Preferred Qualifications: Experience preparing 510(k), CE Mark, or similar submissions. Familiarity with digital pathology, imaging devices, or software as a medical device (SaMD). Certification in Regulatory Affairs (e.g., RAPS RAC) is a plus. Show more Show less

Understanding human capabilities and limitations (cognitive, physical, sensory). Applying ergonomic principles to device design to reduce user strain and error. Familiarity with FDA guidance on usability engineering and human factors. Understanding of IEC 62366-1 standards for usability in medical devices

Experience: 4-8 Years Location: Bangalore Usability Engineer, Usability Assessments, Medical product Usability. Formative evaluation, Summative Evaluations, Requirements Gathering, Documentation, user survey. Observation and Moderation, UFMEA, Task Analysis. Knowledge in IEC 62366, HE 75., Human Factor Engineering

Design quality engineer with minimum 10 years of experience in the medical device industry, specializing in product quality complaints management, regulatory reporting, new product design & development, and risk management. Experience in handling Medical devices including Active Devices, Software as a Medical Device, Disposables. Working on product DHF, design input, design output, product risk management, usability, verification, and validation efforts. Extensive expertise in ensuring compliance with global regulatory standards, including FDA (21 CFR Part 820) and EU MDR. Proven ability to navigate complex regulatory landscapes, secure product approvals, and facilitate successful product launches. Strong background in Biomedical Instrumentation Engineering, coupled with hands-on experience in driving cross-functional collaboration, complaint resolution, and continuous improvement initiatives. Proficient at leading complaint investigations, conducting trend analysis, and maintaining high standards of product quality and safety across the development lifecycle. Experience in DHF Gap assessments and Remediation activities. Experience in Medical Device SotA standard gap assessment for EU MDR and 510k projects. Implemented and Maintained quality systems according to ISO 13485:2016 and ISO 9001:2015. Performed Internal Quality Audits according to ISO 13485:2016 and ISO 9001:2015. Should Performed risk assessments according to ISO 14971:2019. Experience in Planning software verification and validation activities by identifying test requirements. Should have Worked on Technical documents like Trace matrix, STED, Design inputs, LRS. Should Perform Gap assessments and remediation activities for IEC 60601-1 series, IEC 62304, IEC 62366-1, ISO 11607-1, ISO 11607-2 and other medical device standards. Have knowledge in Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Hands on experience in labeling activities based on ISO 20417 and ISO 15223-1.

Role & responsibilities: The individual should be a team player who is willing to collaborate and work in cross functional teams across geographies and cultures. The candidate should be well versed with overall R&D, Quality, and Regulatory processes for medical devices. Lead HFID projects including development of study plans and feasibility. Participate and support in data collection Implement BSC global PLCP process with required SOPs suitable for regional / emerging market projects. Lead projects to integrate HFID into ongoing projects by considering customer insights (voice of customer, voice of business, voice of regulatory, voice of technology) Voice of Business - Work closely with regional, in country and upstream marketing to align the needs-based opportunities with business strategy. Voice of Customer - Develop customer insights processes and tools like Biodesign, Ethnography, contextual innovation and implement the same to develop a portfolio of prioritized customer needs; with focus on all stakeholders (5Ps Patient, physician, payer, provider and policy makers) Develop and deliver Innovative products and solutions to meet the customer and business needs. Ensure that the Voice of Value is captured in the potential solutions. Test proof of concept prototypes with customers testing in simulated environments Skill Sets: Must have - Experience in collecting, analyzing and interpreting data/statistics Analyzing the interaction between people and machinery/equipment Assessing the design of products/systems via practical experiments and Test methods Working knowledge of IEC 62366 and HE 75 Guidelines. Undertaking risk assessments within the workplace Ensuring that products/systems meet user needs Test proof of concept prototypes with customers testing in simulated environments Responsible for working closely with several cross functional colleagues marketing, clinical, regulatory, pre-clinical and global R&D. Keywords & Tools: Human Factor Industrial Designer ( HFID ) projects development IEC 62366 concept prototypes PLCP process with required SOPs IEC 62366 & HE 75 Guidelines.

Role & responsibilities: Process Development &Optimization Define, document, and improve engineering workflows, protocols, and D&D procedures. Collaborate with cross-functional teams (Design, QA/RA, Manufacturing, Supply Chain) to standardize and streamline development processes. Support Design Control processes including Design Inputs/Outputs, Verification, and Validation activities. Technical Documentation Management Create, maintain, and control engineering documentation such as: Design History Files (DHF) Device Master Records (DMR) Engineering Change Orders (ECO) Risk Management Files (ISO 14971) Ensure traceability and version control using QMS tools. Assist in the preparation and formatting of documents for regulatory submissions (FDA, EU MDR). Compliance & Quality Support Ensure documentation and processes meet applicable standards: ISO 13485, 21 CFR Part 820, IEC 60601, and other regulatory requirements. Support internal and external audits by providing required documentation and process maps. Knowledge Transfer & Team Support Maintain structured repositories of technical documentation and templates. Train engineers and D&D staff on documentation best practices, process adherence, and use of documentation tools. Tools & Systems Use and help maintain Product Lifecycle Management and Quality Management Systems (QMS). Work with tools such as SolidWorks PDM, Windchill, Arena, or equivalent for document and change control. Preferred candidate profile

Designation: Staff Specialist Labeling & Technical Publications Experience: 7–11 years Location: Gurgaon (GGN) or Bangalore (BLR) Interview Rounds: 8 Work Mode: Hybrid / Onsite Role Overview We are seeking a highly skilled professional to manage and coordinate global labeling and technical publications for medical device products. This role involves regulatory documentation, translation workflows, quality compliance, and cross-functional project leadership within a regulated environment. Key Responsibilities Manage and approve labeling jobs using tools like Microsoft Teams Planner and PLM systems. Coordinate document translations with external vendors and ensure regulatory compliance. Publish approved documents to global portals and maintain accurate versions. Lead and support Engineering Change Requests (ECR/ECN) related to labeling and documentation. Act as the local labeling lead for global projects, tracking progress, managing stakeholders, and reporting risks. Ensure compliance with global quality and regulatory standards (EU MDR, ISO 14971, IEC 62366). Support risk management processes and integrate risk measures into product labeling. Review quality assurance documentation related to product sustenance and lifecycle management. Manage label printing for regulatory submissions and large-scale updates. Must-Have Skills & Qualifications 7–11 years of work experience, with 5+ years in technical writing, labeling, or quality assurance in the medical device domain. Hands-on experience with documentation systems such as onePLM, SharePoint, or similar. Solid understanding of regulatory frameworks including EU MDR, ISO 14971, and IEC 62366. Strong project management capabilities with the ability to manage multiple projects and timelines. Bachelor’s degree in Engineering, Science, or a related technical field. Excellent communication and stakeholder management skills.