Regulatory Medical Writer – CDSCO & EU MDR
Location: Bangalore, India
Job Type: Full-Time
Experience Required: Freshers to 2 Years of Experience Preferred (0–2 Years)
About Remidio
Remidio is a globally recognized healthcare technology company revolutionizing ophthalmology through artificial intelligence-driven diagnostic solutions and advanced ophthalmic medical devices. With a strong focus on preventive healthcare and early disease detection, Remidio has become one of the leading innovators in retinal imaging, diabetic retinopathy screening, glaucoma detection, and AI-powered eye care solutions.
The company is the first in India to receive CDSCO approval for adaptive ophthalmic AI technology and has achieved CE Mark certification under EU-MDR standards. Remidio’s FDA-registered devices are currently used across 40+ countries and have supported screening for over 16 million patients worldwide.
Driven by innovation, regulatory excellence, and patient-centric healthcare, Remidio continues to expand its global impact in medical technology, digital health, and clinical diagnostics.
Job Overview – Regulatory Medical Writer
Remidio is hiring a detail-oriented and scientifically driven Regulatory Medical Writer to support the preparation of high-quality clinical and regulatory documentation for global medical device submissions. This role is ideal for candidates interested in Regulatory Affairs, Clinical Evaluation Writing, Medical Devices, EU MDR Documentation, CDSCO Regulatory Compliance, and Post-Market Surveillance reporting.
The selected candidate will work closely with cross-functional teams including Regulatory Affairs, Clinical Research, Quality Assurance, and Product Development teams to create compliant clinical evaluation and regulatory documents aligned with international standards and medical device regulations.
This opportunity is highly suitable for life sciences graduates, pharmacy professionals, biomedical professionals, biotechnology candidates, and freshers aspiring to build careers in Regulatory Medical Writing and Medical Device Regulatory Affairs.
Key Responsibilities
Prepare, draft, review, and maintain regulatory medical writing documents including:
Clinical Evaluation Plans (CEP)
Clinical Evaluation Reports (CER)
Post-Market Surveillance (PMS) Reports
Regulatory submission documents
Literature review summaries
Clinical evidence documentation
Conduct literature searches using scientific databases such as PubMed, Cochrane Library, and other medical literature platforms.
Extract, analyze, and summarize relevant clinical data and published studies for regulatory submissions.
Collaborate with Regulatory Affairs, Clinical, Quality, and Product teams to gather scientific and technical information.
Ensure all regulatory documents comply with:
CDSCO Guidelines
EU MDR Regulations
Clinical Evaluation Requirements
Post-Market Surveillance standards
International medical device regulatory frameworks
Support audit readiness activities and provide documentation support during regulatory inspections.
Stay updated with evolving global medical device regulations, regulatory guidance documents, and compliance requirements.
Required Qualifications
Bachelor’s degree in:
Pharmacy
Life Sciences
Biotechnology
Biomedical Engineering
Clinical Research
Medical Sciences
Or related scientific disciplines
Freshers with strong scientific writing skills may apply.
Candidates with 0–2 years of experience in:
Regulatory Medical Writing
Clinical Research
Regulatory Affairs
Medical Device Documentation
Pharmacovigilance Documentation
will be preferred.
Understanding of:
CDSCO regulations
EU MDR requirements
Clinical Evaluation processes
Medical device regulatory documentation
Experience with scientific literature review and evidence extraction is an advantage.
Strong written and verbal communication skills.
Excellent attention to detail, analytical thinking, and document management abilities.
Ability to work independently in a fast-paced regulatory and clinical environment.
Preferred Skills
Regulatory Writing
Medical Writing
Clinical Evaluation Report Writing
CEP & CER Documentation
EU MDR Compliance
CDSCO Submission Documentation
Post-Market Surveillance (PMS)
Scientific Literature Review
PubMed & Cochrane Literature Search
Medical Device Regulatory Affairs
Clinical Documentation Management
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