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Regulatory Medical Writer

Remidio
Remidio
0-4 years
Not Disclosed
Bangalore, Bengaluru, India
10 May 7, 2026
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title

Regulatory Medical Writer (0–2 Years Experience)
Location: Bangalore
Employment Type: Full-Time


About the Company

Remidio is a global pioneer in AI-driven eye care, transforming healthcare through innovative ophthalmic equipment.

  • First in India to receive CDSCO approval for adaptive ophthalmic AI

  • CE marked under EU-MDR

  • Focused on early detection of:

    • Diabetic Retinopathy

    • Glaucoma

    • Age-related Macular Degeneration (AMD)

  • Expanding into systemic disease detection such as cardiovascular disease (CVD) and chronic kidney disease (CKD)

  • FDA-registered devices

  • Screened over 16 million patients across 40+ countries

Founded 15 years ago, Remidio aims to democratize preventive eye care by combining innovation with empathy to make quality healthcare accessible globally.


Position Overview

We are seeking a highly motivated and detail-oriented Regulatory Medical Writer.

The role involves developing and managing clinical regulatory documents for:

  • CDSCO (Central Drugs Standard Control Organization)

  • EU Medical Device Regulation (EU MDR)

  • Other global regulatory bodies

You will play a key role in preparing critical submissions including clinical and post-market documentation.


Key Responsibilities

Clinical Documentation & Writing

  • Draft, review, and edit:

    • Clinical Evaluation Plans (CEP)

    • Clinical Evaluation Reports (CER)

    • Post-Market Surveillance (PMS) Reports

    • Other regulatory submissions

Data Analysis & Collaboration

  • Work with cross-functional teams to gather and analyze clinical data

  • Extract and interpret relevant clinical studies for documentation

Regulatory Compliance

  • Ensure all documents are accurate, complete, and compliant with:

    • CDSCO guidelines

    • EU MDR requirements

    • Other applicable regulatory standards

Regulatory Knowledge

  • Develop and maintain expertise in global regulatory frameworks

  • Stay updated on changes in regulations and communicate impacts to stakeholders

Audit & Inspection Support

  • Assist in regulatory inspections and audits when required


Qualifications

Education

  • Bachelor’s degree in a scientific or technical discipline

  • Advanced degree preferred

Experience

  • 0–4 years of experience in regulatory medical writing

  • Experience in pharmaceutical, biotechnology, or medical device industries preferred

  • Exposure to CDSCO and EU MDR documentation is an advantage

Skills & Competencies

  • Proficiency in literature search tools (e.g., PubMed, Cochrane)

  • Ability to extract and summarize clinical research effectively

  • Strong understanding of clinical evaluation and PMS regulatory requirements

  • Excellent written and verbal communication skills

  • Strong attention to detail

  • Good organizational and time management skills

  • Ability to work independently and in a fast-paced environment