Meril is hiring for the position of Regulatory Affairs Officer for locations including Valsad, Vapi, and Daman & Diu. The role focuses on clinical evaluation documentation for medical devices, including Clinical Evaluation Reports (CERs), literature reviews, clinical evidence assessment, and regulatory compliance.

Job Details

Positions

Regulatory Affairs Officer – 1 Opening

The position involves preparing and reviewing clinical evaluation documentation and assessing scientific and clinical evidence related to medical devices.

Responsibilities

• Prepare, review, and update Clinical Evaluation Reports (CERs) for medical devices according to applicable regulatory requirements and internal procedures.
• Conduct systematic literature searches and reviews using PubMed, Google Scholar, and other relevant scientific sources.
• Identify, evaluate, and summarize clinical and scientific evidence related to medical devices, including intended purpose, safety, performance, and clinical benefits.
• Support preparation and maintenance of Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Clinical Literature Review (CLR), and other clinical evaluation documents.
• Critically appraise scientific literature and assess the relevance, quality, and applicability of clinical data.
• Support evaluation of clinical safety, performance, benefit-risk profile, and state-of-the-art information for medical devices.
• Review and summarize clinical investigation data, PMS, PMCF, vigilance data, and other relevant clinical evidence.
• Coordinate with Regulatory Affairs, R&D, Quality Assurance, Clinical, and other cross-functional teams.
• Ensure clinical evaluation documentation is scientifically sound, traceable, consistent, and compliant with applicable regulatory requirements.
• Support responses to Notified Body and regulatory authority queries related to clinical evaluation and clinical evidence.
• Maintain references, literature records, evidence tables, and supporting documentation.
• Keep updated with requirements related to EU MDR, clinical evaluation, PMCF, PMS, and medical-device clinical evidence.

Eligibility and Qualifications

Candidates should have:

• M.Sc. in Zoology, Life Sciences, Biotechnology, Microbiology, Biomedical Sciences, Pharmacy, or a related field.
• Relevant experience in medical writing, clinical research, clinical evaluation, scientific writing, or regulatory documentation.
• Candidates with 6 months or more of medical writing experience will be preferred.
• Basic understanding of medical devices and clinical evaluation principles.
• Basic understanding of EU MDR 2017, particularly requirements related to clinical evaluation and clinical evidence, is preferred.

The JD also lists B.Tech/B.E. in Biomedical Engineering and B.Sc. in Agriculture under UG education, and MS/M.Sc. (Science) in Biotechnology under PG education.

Required Skills

• Scientific literature search and review
• Clinical evidence evaluation
• Scientific and medical writing
• Critical appraisal of research papers
• Clinical evaluation documentation
• Regulatory documentation
• Regulatory Affairs
• Drug Regulatory Affairs
• Clinical Research
• Documentation
• Investigation
• Licensing
• Knowledge of PubMed, Google Scholar, and ClinicalTrials.gov
• Good written English
• Analytical and critical-review skills
• Attention to detail
• Cross-functional coordination
• Ability to manage multiple documents and deadlines
• Proficiency in MS Word, Excel, and PowerPoint

Application Details

Application Link