OptraSCAN

OptraSCAN India Pvt Ltd is an innovative subsidiary of a U.S. digital pathology leader, delivering cost-efficient scanner hardware, AI software, and scalable services to labs globally. With strong leadership, impressive funding, and strategic partnerships, the company continues to advance digital pathology access — particularly in under-resourced regions, backed by a robust growth trajectory and mission-driven vision. www.optrascan.com We are seeking a Senior Software Engineer with 10–15 years of experience in C# and WPF to lead the development of high-performance desktop applications. This role requires strong architectural understanding, hands-on coding skills, and the ability to contribute to product decisions and cross-functional collaboration. location - Pune (Near Pune station) Work timing- 8.30 am to 5.30 pm 5 days work from office Key Responsibilities: • Architect, design, and implement scalable WPF desktop applications using C# and .NET Framework/.NET Core • Own complete modules and features from design to deployment • Apply MVVM and other design patterns to ensure modular, testable, and maintainable code • Optimize application performance and implement multi-threaded workflows where needed • Collaborate closely with product managers, QA teams, hardware integration engineers, and UX/UI designers • Write clean, well-documented, and well-tested code using modern software engineering practices • Conduct peer code reviews and provide mentorship to junior developers • Integrate RESTful APIs, third-party SDKs, and external services as part of the application workflow • Implement version control and CI/CD pipelines (Git, Azure DevOps, etc.) • Work with SQL or embedded databases such as SQL Server or SQLite • Explore and apply libraries like Prism or Reactive UI for enhanced WPF development • Interface with hardware and embedded systems, especially in imaging, healthcare, or industrial domains • Stay updated with evolving best practices in .NET ecosystem and proactively improve system architecture Required Qualifications: • Bachelor’s or Master’s degree in Computer Science, Engineering, or a related field • 10–15 years of professional experience in software development, with a strong focus on C# and WPF • Deep expertise in MVVM architecture and WPF/XAML development • Proven track record of delivering robust desktop applications in complex domains • Solid grasp of OOP, data structures, and algorithmic thinking • Strong debugging, performance profiling, and troubleshooting skills • Experience in full software development lifecycle and agile methodologies

Quality Assurance Engineer - Company Overview: Optra Scan Pvt Ltd is a leading provider of digital pathology solutions, revolutionizing the way pathology practices worldwide, managing and interpreting diagnostic information. Our cutting-edge technology empowers pathologists to improve efficiency, accuracy, and patient care through digitalization and artificial intelligence. URL - www.optrascan.com Job Summary: The QA Engineer will support and maintain the Quality Management System (QMS) in compliance with regulatory requirements (e.g., ISO 13485, IEC 62304, FDA 21 CFR Part 820). The role involves ensuring that all products, processes, and documentation meet OptraSCAN’s high standards for quality and regulatory compliance. Key Responsibilities:- · Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable international quality standards. · Support design control, risk management, validation, and verification processes for scanners and software. · Maintain and improve the Quality Management System (QMS) across departments. · Review and approve SOPs, DHRs, DHFs, CAPAs, NCRs, and change controls. · Conduct internal audits and support external audits (e.g., customer, notified bodies, FDA). · Collaborate with engineering, manufacturing, and regulatory teams to ensure product quality at every stage of the lifecycle. · Support software validation and documentation of AI algorithms per FDA/CE/MDR requirements. · Participate in supplier qualification and vendor audits. · Monitor and report on key quality metrics (e.g., defect rates, complaints, CAPA status). · Ensure traceability and document control throughout product development and release.lease. Qualifications :- · Bachelor’s degree in biomedical engineering, Quality, Life Sciences, or related field. · 3–6 years’ experience in a medical device, diagnostics, or regulated health tech environment. · Familiarity with digital pathology, AI in healthcare, imaging devices, or SaMD is a plus. · Strong knowledge of ISO 13485, ISO 14971, IEC 62304, FDA QSR, and EU MDR/IVDR regulations. · Experience with QMS tools, document control systems, and audit practices. · Excellent written and verbal communication skills. · Detail-oriented,with strong problem-solving and cross-functional collaboration abilities.

Customer Service Specialist: Company Overview: Optra Scan Pvt Ltd is a leading provider of digital pathology solutions, revolutionizing the way pathology practices worldwide, managing and interpreting diagnostic information. Our cutting-edge technology empowers pathologists to improve efficiency, accuracy, and patient care through digitalization and artificial intelligence. www.optrascan.com Job Description: As a Customer Service Specialist at Optra Scan Pvt Ltd, you will be at the forefront of our commitment to excellence in customer satisfaction and retention. You will play a pivotal role in ensuring that our clients receive unparalleled support and service, fostering long-term relationships and driving the success of our digital pathology solutions. Responsibilities : Customer Engagement: Proactively engage with clients to understand their needs, challenges, and objectives. Serve as the primary point of contact for all customer inquiries, providing timely and effective responses. • Issue Resolution: Address customer concerns and technical issues promptly, coordinating with internal support teams to ensure timely resolution and minimize downtime. Escalate complex issues as needed and follow up to ensure customer satisfaction. • Training and Onboarding: Coordinate and conduct training sessions for clients on the use of our digital pathology platform, ensuring smooth onboarding and adoption. Provide ongoing support and guidance to optimize the client’s experience and maximize value. • Feedback Collection: Gather feedback from clients regarding their experiences with our products and services, as well as their evolving needs and preferences. Translate feedback into actionable insights to drive product enhancements and service improvements. • Customer Success Planning: Develop and execute strategic plans to drive customer success and retention. Collaborate with cross-functional teams to identify opportunities for upselling, cross-selling, and expanding our footprint within client accounts. Requirements: • Bachelor's degree in business administration, life sciences, engineering, or a related field (Preferred) • 5+ years of experience in customer relations, account management, or customer support roles, preferably in the healthcare or life sciences industry. • Strong understanding of pathology workflows and laboratory operations. • Excellent communication and interpersonal skills, with the ability to build rapport and trust with clients at all levels. • Technical aptitude and the ability to troubleshoot software and hardware issues. • Proficiency in CRM software and other relevant tools for customer relationship management. • Analytical mindset with the ability to interpret data and derive actionable insights. • Demonstrated ability to manage multiple projects and priorities simultaneously in a fast-paced environment. Join Optra Scan Pvt Ltd and contribute to our mission of transforming pathology through innovation and excellence in customer service!

Optra Scan Pvt Ltd is a renowned provider of digital pathology solutions, transforming the landscape of pathology practices worldwide by streamlining the management and interpretation of diagnostic information. With our innovative technology, we empower pathologists to enhance efficiency, precision, and patient care through the integration of digitalization and artificial intelligence. As a Technical Writer - Regulatory at OptraSCAN, you will play a pivotal role in creating, organizing, and updating regulatory documentation essential for product approvals, certifications, and market entry across global jurisdictions. This position demands a blend of strategic regulatory planning and meticulous technical writing focused on ensuring adherence to international standards like ISO 13485, FDA 21 CFR Part 820, EU MDR, and other relevant regulations. Your responsibilities will include preparing and managing various regulatory documents such as Technical Files, Design Dossiers, Clinical Evaluation Reports (CERs), Risk Management Files, Declarations of Conformity, and FDA submissions. Collaboration with cross-functional teams comprising R&D, QA, Clinical, and Marketing departments will be essential to gather inputs for the compilation of submission materials. In the realm of technical writing, you will be tasked with crafting, reviewing, and refining Standard Operating Procedures (SOPs), work instructions, user manuals, labeling, and Instructions for Use (IFUs) to ensure accuracy, clarity, and regulatory compliance. Your ability to translate intricate technical information into easily comprehensible documentation will be critical in this role. Staying abreast of regulatory updates such as EU MDR and FDA guidelines will be imperative to ensure that internal processes and documentation align with the latest standards. Compliance with key regulations like ISO 13485, ISO 14971, IEC 62304, IEC 60601, EU MDR 2017/745, and FDA 21 CFR Part 820 will be a focal point of your responsibilities. Moreover, you will provide support for internal audits and inspections by maintaining meticulous and readily accessible documentation. Assistance in Corrective and Preventive Actions (CAPA) documentation and post-market surveillance reporting will also be expected as part of your Quality System Support duties. To qualify for this role, you should hold a Bachelor's or Master's degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field, accompanied by at least 3-6 years of experience in regulatory writing or regulatory affairs within the medical device or healthcare product domain. Proficiency in global medical device regulatory frameworks, exceptional written English and technical writing skills, as well as strong organizational and project management capabilities are essential prerequisites. Preferred qualifications for this position include prior experience in preparing 510(k) submissions, CE Mark applications, or similar regulatory filings. Knowledge of digital pathology, imaging devices, or software as a medical device (SaMD) would be advantageous, along with a certification in Regulatory Affairs such as RAPS RAC. Join Optra Scan Pvt Ltd in revolutionizing the digital pathology landscape and leveraging your regulatory expertise to drive impactful advancements in healthcare technology.,

Job Title: TL/ Manager -AIML (Image Processing )(Healthcare /Medical domain experience is preferable) Experience - Min 7yrs to 12years . Company: Optra Scan India Pvt Ltd Location: Pune (Near Pune Station) About Optra Scan: Optra Scan is a leading provider of AI-powered digital pathology solutions, revolutionizing the way pathology is practiced worldwide. Our cutting-edge technology enables pathologists and researchers to make accurate diagnoses efficiently and effectively, ultimately improving patient outcomes. Job Description: Optra Scan is seeking a talented and motivated AI/ML professional to join our dynamic team. As an AI/ML professional, you will play a pivotal role in the development and implementation of machine learning algorithms and AI models to enhance our digital pathology platform. You will collaborate closely with cross-functional teams to drive innovation and deliver solutions that address complex challenges in healthcare. Responsibilities: Design, develop, and implement machine learning algorithms and AI models for digital pathology applications. Analyze large-scale medical imaging datasets and extract meaningful insights to improve diagnostic accuracy and efficiency. Optimize algorithms for performance, scalability, and robustness in real-world clinical settings. Collaborate with software engineers, pathologists, and data scientists to integrate AI/ML solutions into our digital pathology platform. Stay updated on the latest advancements in AI/ML technologies and contribute to continuous learning and improvement within the team. Participate in code reviews, documentation, and knowledge sharing activities to maintain high standards of software quality and best practices. Requirements: Python, TensorFlow, PyTorch, MATLAB, CUDA programming, Image Processing, NLP, Neural networks and multithreading knowledge Min. 6+ yr of relevant experience Knowledge of AI/ML technology, Data Science, NLP, Machine learning, Imaging Algorithms development in medical domain. object oriented design/development skills, Knowledge of image analysis methods, techniques and practices Experience in C++ and Python is required If you would like to explore this opportunity kindly revert with resume.

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: Bachelor’s or master’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field. 2–5 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.

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

Company Overview: Optra Scan Pvt Ltd is a leading provider of digital pathology solutions, revolutionizing the way pathology practices worldwide, managing and interpreting diagnostic information. Our cutting-edge technology empowers pathologists to improve efficiency, accuracy, and patient care through digitalization and artificial intelligence. Job Description: OptraSCAN is seeking a highly detail-oriented and knowledgeable Technical Writer - Regulatory 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. 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 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. 36 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

About OptraHEALTH:- OptraHEALTH® is at the forefront of healthcare innovation, leveraging cutting-edge Artificial Intelligence to transform patient care and streamline operations for providers and payors alike. At the heart of this revolution is our flagship AI platform, HealthFAX™. HealthFAX™ isn't just another healthcare tool—it's a comprehensive AI ecosystem designed to redefine the entire patient journey. From the moment a patient considers seeking care to long after their visit, HealthFAX™ is there, invisibly orchestrating a seamless, efficient, and patient-centric experience. Role Summary:- We are looking for a highly motivated and field-savvy Business Development Executive to drive the adoption of our AI-powered mobile apps and healthcare software solutions across clinics, hospitals, diagnostic centers, and individual practitioners in India. The role also involves coordination for expanding our AI platform in revenue cycle management (RCM) to overseas markets. This position is ideal for someone with experience in pharmaceutical or medical representative roles, who is confident in meeting doctors, administrators, and hospital staff face-to-face, and who can clearly explain the benefits of software solutions. This job requires frequent on-ground visits, relationship-building, and strong communication skills. Key Responsibilities:- 1.) Field Sales & Outreach: Regular door-to-door visits to doctor clinics, diagnostic centers, hospitals, and nursing homes to introduce and demonstrate AI-powered mobile apps for: Patient report explanation Digital intake and health histories Patient education and engagement 2.)Software Demonstrations: Explain product features and benefits in simple terms to doctors, clinic staff, hospital admin teams, and even patients when required. Comfort with speaking in English and local languages is preferred. 3.)Customer Relationship Management: Build strong, ongoing relationships with key stakeholders including doctors, hospital purchase teams, diagnostic lab managers, and administrators. 4.)Feedback & Product Improvement: Gather on-ground feedback from healthcare professionals to share with internal product and development teams for improvements. 5.)Sales Funnel & Reporting: Maintain CRM records, track leads, prepare weekly reports on field visits, and ensure timely follow-ups and closures. Key Qualifications:- 3–5 years of experience in: Healthcare product sales / SaaS sales Pharma / medical representative role Or a mix of healthcare and software field marketing Strong interpersonal skills with ability to speak confidently to doctors, hospital admins, and patients. Familiarity with the functioning of clinics, labs, and hospitals in Tier 1 and Tier 2 cities Willingness to travel extensively for field visits Fluent in English and at least one regional language Basic understanding of healthcare systems, mobile apps, or digital health products is a bonus Key Performance Indicators (KPIs):- Monthly Field Visits : Target number of clinics/hospitals visited, and product demos completed Lead Conversion Rate : Percentage of demos leading to successful onboarding or pilot agreements Client Retention : Number of accounts maintaining active usage after 3 and 6 months Territory Expansion : Growth in new cities/regions covered and accounts opened Feedback Quality : Number of actionable feedback items captured and communicated to the team Revenue Contribution : Overall contribution to sales or licensing targets from the assigned region