OptraSCAN’s Careers

Location : Pune (work from office)

Experience : 3-6 years

Notice : Immediate to 15 days

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.

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.

Interested candidates can mail in their CV to hr@optrascan.com

Location : Pune (work from office)

Experience : 3-5 years

Notice : Immediate to 15 days

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.

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:

• Bachelor’s or master’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field.
• 3–5 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.

Interested candidates can mail in their CV to hr@optrascan.com

Location : Pune (work from office)

Experience : 3-5 years

Notice : Immediate to 15 days

About the Role:

OptraSCAN is advancing precision diagnostics through digital pathology. As Quality Assurance, you will support the integrity and effectiveness of the Quality Management System (QMS) across our Digital Pathology Systems and Software as a Medical Device (SaMD) portfolio. You will contribute to compliance with ISO 13485:2016, 21 CFR 820, EU IVDR, MDSAP, and Indian Medical Device Rules 2017, working across design, manufacturing, and post-market activities. This role collaborates with R&D, Regulatory Affairs, Manufacturing, Supply Chain, and Commercial teams.

Core skills:

• Assist in maintaining and updating QMS documentation (SOPs, Work Instructions, Records).
• Help coordinate internal audits and prepare documentation for external audits.
• Support the training process by organizing sessions and maintaining training records.
• Perform basic QC checks and inspections under supervision.
• Assist with tracking and follow-up on CAPA actions.
• Help maintain supplier documentation and support risk management files.
• Ensure proper document control and record retention in compliance with ISO 13485.
• Promote awareness of quality procedures across departments.

Qualifications:

• Diploma or Bachelor s in Mechanical, Engineering, or related field.
• 3-5 years of experience in a quality or manufacturing environment.
• Familiarity with ISO 13485 and medical device regulations is an advantage.
• Certification - Internal Auditor ISO 13485
• Training certificates - ISO 14971

Skills Required:

• Basic understanding of QMS principles and ISO standards.
• Good attention to detail and documentation accuracy.
• Strong organizational and communication skills.
• Proficient in Microsoft Office (Word, Excel, Outlook).
• Ability to follow procedures and work collaboratively in a team.

Interested candidates can mail in their CV to hr@optrascan.com

Location : Pune,India

Experience : 10–12 years

Notice : 1-2 months

Position Overview

The Finance Manager will be a key member of OptraSCAN’s leadership team, responsible for shaping the company’s financial architecture during its next stage of growth. This role will oversee accounting, FP&A, investor relations, and cross-border compliance between India and the United States. The ideal candidate combines strong technical finance skills with strategic insight into scaling a high growth medtech or technology business.

Key Responsibilities:

Strategic Financial Leadership

• Develop and execute long-term financial strategies aligned with OptraSCAN’s growth objectives, funding milestones, and global expansion plans.
• Lead financial modeling, scenario planning, and sensitivity analyses to guide decision-making and investor communications.
• Partner with the CEO and leadership team to ensure profitability, working-capital efficiency, and disciplined cash flow management.

Financial Planning, Analysis & Control

• Lead annual and quarterly budgeting, forecasting, and variance reporting across all global entities.
• Establish frameworks for cost control, margin tracking, and return on investment across product lines (scanners, AI, SaaS, and services).
• Build dashboards and analytics for real-time visibility into performance, overheads, and cost centers.

Accounting, Compliance & Audit

• Oversee all accounting functions, including payables, receivables, payroll, GL, and reconciliations, ensuring timely and accurate monthly and annual closes.
• Ensure compliance with Indian Accounting Standards (IndAS), US GAAP,and IFRS, maintaining alignment between global entities.
• Manage all tax, transfer pricing, and intercompany compliance, including FEMA, GST, TDS, Form 3CEB, 15CA/CB, SEZ, and RBI filings.
• Coordinate statutory, internal, and investor audits across India and the US, ensuring transparency, accuracy, and audit readiness.
• Structure and oversee cross-border transactions, profit repatriation, and fund transfers to optimize taxation while maintaining full legal compliance.

Investor Relations & Fund Management

• Manage investor reporting, quarterly updates, and board-level financial presentations.
• Track utilization of raised funds, ensure alignment with shareholder agreements, and maintain transparency with stakeholders.
• Support future fundraising rounds, valuations, due diligence, and investor onboarding.

Cross-Functional Partnership

• Work closely with Operations, Sales, and R&D to align budgets with execution goals.
• Implement financial systems integration (ERP, CRM, accounting tools) to digitize and streamline processes.
• Provide business insights and ROI analysis for strategic initiatives, product launches, and regional expansion.

Qualifications:

• Education: Chartered Accountant (CA) or CPA; MBA (Finance) preferred.
• Experience: 10–12 years of progressive finance leadership, including at least 5 years in a senior management role overseeing cross-border operations between India and the US.
• Proven track record in fundraising, financial planning, global compliance, and investor relations.
• Strong grasp of Indian and US financial regulations, including tax structures, GAAP/IFRS standards, and international accounting principles.
• Experience with financial systems such as QuickBooks, Zoho Books, Tally, or ERP-based reporting.
• Excellent analytical, strategic, and leadership skills with high attention to accuracy and execution.

What Success Looks Like

• Unified and transparent financial reporting across India, US, and global entities.
• Streamlined audits, clean compliance, and optimized fund flow between entities.
• Clear understanding of product-level economics, costs, and margins driving executive decision-making.
• Finance function operating as a strategic business partner—enabling 2–3× organizational growth.

Compensation & Benefits

• Competitive salary with performance-based incentives.
• Potential for ESOPs / equity participation for the right candidate.

Interested candidates can mail in their CV to hr@optrascan.com

Location : Kolkata,India

Experience : 3-6 years

Notice : Immediate to 15 days

Job Summary

We are seeking a skilled and customer-oriented Field Service Engineer to join our team. The ideal candidate will be responsible for the installation, setup, and demonstration of our products at client sites, ensuring optimal performance and customer satisfaction. This role requires a mix of technical expertise, problem-solving skills, and excellent communication abilities.

Key Responsibilities:

• Perform installation, configuration, and testing of products and equipment at customer sites.
• Conduct product demonstrations and training sessions for clients, explaining features and usage.
• Troubleshoot and resolve technical issues on-site, providing timely solutions.
• Maintain accurate service reports and documentation for installations, demos, and maintenance.
• Collaborate with sales and support teams to ensure smooth delivery of products and services.
• Provide technical support and guidance with the client’s post-installation.
• Ensure compliance with safety standards and company policies during all field operations.

Qualifications & Skills:

• Bachelor’s degree in engineering, Electronics, Mechanical, or related field (or equivalent experience).
• Proven experience in field service, installations, or technical support.
• Strong technical troubleshooting skills and ability to learn new products quickly.
• Excellent communication and interpersonal skills for client interaction.
• Ability to travel frequently and work in diverse environments.
• Customer-focused attitude and problem-solving mindset.

Preferred

• Experience with product demos and customer training.
• Familiarity with diagnostic tools, software, and hardware installation.
• Certification in relevant technical areas (optional but advantageous).

Interested candidates can mail in their CV to hr@optrascan.com

Location : San Jose, California (Hybrid)

Experience : 12+ years

Notice : Immediate to 15 days

Role Overview:

The Director of R & D will lead the innovation strategy, research programs, and next-generation product development across imaging hardware, AI/ML, optics, and software platforms. This role will guide cross-functional teams to bring high-performance digital pathology products from concept to commercialization, ensuring quality, scalability, and regulatory compliance.

Key Responsibilities:

Strategic Leadership

• Define and drive the R&D roadmap aligned with company vision and market needs.
• Identify emerging technologies (AI, optics, automation, cloud) for future product integration.
• Collaborate with executive leadership to shape long-term product strategy.

Product & Technology Development

• Lead the design, development, and optimization of digital pathology scanners, imaging systems, and AI algorithms.
• Oversee feasibility studies, prototyping, and performance validation.
• Ensure integration of hardware, software, and cloud technologies into cohesive solutions.
• Guide research into optics, image processing, robotics, and high-resolution imaging systems.

Team Leadership & Collaboration

• Manage and mentor cross-functional engineering teams (optical, mechanical, embedded, software, AI/ML).
• Foster a culture of innovation, collaboration, and accountability.
• Work closely with Clinical, Regulatory, and Quality teams to ensure product compliance and readiness for FDA/CE certifications.

Project & Process Management

• Establish processes for efficient R&D execution, documentation, risk management, and product lifecycle management.
• Manage budgets, timelines, and resource allocation.
• Evaluate and manage external partnerships, vendors, and research institutions.

Regulatory, Quality & Compliance

• Ensure R & D activities comply with ISO 13485, IEC standards, and FDA/CE requirements.
• Support regulatory submissions with technical documentation and data.

Qualifications & Experience:

Education

• Master’s or PhD in Biomedical Engineering, Optics, Imaging Science, Electrical Engineering, Computer Science, or related fields.

Experience

• 12+ years of product development experience in medical devices, imaging systems, digital pathology, or diagnostics.
• Proven experience leading multidisciplinary R&D teams.
• Strong expertise in at least two of the following:
• Optical imaging / microscopy
• Image processing / AI–ML
• Embedded systems & hardware
• Cloud software & data platforms
• Robotics / motion systems

Skills

• Strong technical leadership and ability to translate scientific concepts into commercial products.
• Deep understanding of product development lifecycles for regulated medical devices.
• Excellent communication and documentation skills.
• Strong problem-solving and decision-making abilities.

Interested candidates can mail in their CV to hr@optrascan.com

Location : San Jose, California (Hybrid)

Experience : 8 to 10 years

Notice : Immediate to 15 days

Position Overview:

OptraSCAN Inc. is seeking an experienced Director – Regulatory & Clinical Affairs (USA) to lead regulatory submissions, U.S. FDA interactions, and clinical affairs strategy for our digital pathology and AI-driven diagnostic products. This role will be responsible for ensuring compliance, driving clinical evidence generation, and enabling successful product approvals in the U.S. and global markets.

This is a senior leadership role ideal for candidates with strong experience in medical devices, diagnostics, digital imaging, and SaMD/AI-ML products.

Key Responsibilities:

Regulatory Affairs – U.S. & Global

• Develop and execute regulatory strategies for digital pathology products, imaging devices, and AI/ML-based medical software.
• Lead U.S. FDA submissions including 510(k), De Novo, PMA, Q-sub meetings, responses, amendments, and technical files.
• Prepare regulatory documents including design dossiers, device master files, labeling, CERs, and risk management documentation.
• Act as primary liaison with U.S. FDA and participate in pre-submission meetings, inspections, and audits.
• Oversee global regulatory preparation (EU MDR/IVDR, Canada, Australia, APAC as applicable).

Clinical Affairs

• Develop clinical strategy for U.S. and global product validations.
• Oversee clinical study design, IRB submissions, site selection, investigator management, CRO coordination, enrolment tracking, and study governance.
• Lead data collection, clinical evaluation reports, safety assessments, and post-market clinical follow-ups.
• Ensure compliance with Good Clinical Practice (GCP), clinical regulations, and global standards.

Compliance & Cross-Functional Leadership

• Ensure adherence to ISO 13485, ISO 14971, IEC 62304, IEC 60601, FDA QSR (21 CFR 820), and SaMD guidelines.
• Provide regulatory input into product development, risk analysis, labeling, market claims, and change management.
• Support Quality Assurance in inspection readiness, CAPA, internal audits, and documentation.
• Collaborate with R&D, QA, Product Management, and Operations teams across U.S. and India.

Required Qualifications

• Bachelor’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field (master’s preferred).
• 8 to 10 years of experience in U.S. medical device or diagnostics regulatory affairs and clinical affairs.
• Experience with digital pathology, imaging, scanners, diagnostics, or software-as-a-medical-device (SaMD).
• Strong understanding of global regulatory systems (EU MDR/IVDR, Health Canada, TGA).
• Demonstrated leadership in managing regulatory teams or complex cross-functional projects.

Preferred Qualifications

• RAC (Regulatory Affairs Certification)
• Experience with AI/ML-enabled diagnostic tools
• Experience leading global multi-site clinical trials
• Knowledge of cloud-based digital diagnostic systems

Interested candidates can mail in their CV to hr@optrascan.com