Job highlights

- . 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
- Bachelor s or master s degree in Life Sciences,Biomedical Engineering,Pharmacy,or a related field
- Required Qualifications: .

: 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 transparent, 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.

📌 Regulatory technical writer (Pune)
🏢 OptraSCAN
📍 Pune