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.

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Regulatory technical writer