Technical Writer (Regulatory)

Company Overview:

Optra Scan Pvt Ltd

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.