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