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Regulatory Specialist – Technical Writer

5 years

0 Lacs

Pune Maharashtra India

Posted:16 hours ago| Platform: Linkedin logo

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Skills Required

ai pathology diagnostics microscopy archiving reporting pricing documentation certifications combination strategy writing software compliance mdr design evaluation reports risk management marketing labeling data electrical support audits audit engineering healthcare imaging certification

Work Mode

On-site

Job Type

Full Time

Job Description

About OptraSCAN:

AI-enabled digital pathology solutions


OptraSCAN


Note:


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 62366
  • 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.
  • 2–5 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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