Regulatory Affairs Officer

Role & responsibilities

• To prepare, review, and update Clinical Evaluation Reports (CERs) for medical devices in accordance with applicable regulatory requirements and internal procedures.
  
• To conduct systematic literature searches and literature reviews using databases such as PubMed, Google Scholar, and other relevant scientific sources.
  
• To identify, evaluate, and summarize clinical and scientific evidence related to medical devices, their intended purpose, safety, performance, and clinical benefits.
  
• To support the preparation and maintenance of Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Clinical Literature Review (CLR), and other clinical evaluation documents.
  
• To critically appraise published scientific literature and assess the relevance, quality, and applicability of clinical data.
  
• To support the evaluation of clinical safety, performance, benefit-risk profile, and state-of-the-art information for medical devices.
  
• To review and summarize clinical investigation data, post-market surveillance (PMS), PMCF, vigilance data, and other relevant clinical evidence as required.
  
• To coordinate with Regulatory Affairs, R&D, Quality Assurance, Clinical, and other cross-functional teams for collection and review of required clinical information.
  
• To ensure clinical evaluation documentation is scientifically sound, traceable, consistent, and compliant with applicable regulatory requirements.
  
• To support responses to Notified Body / regulatory authority queries related to clinical evaluation and clinical evidence.
  
• To maintain proper references, literature records, evidence tables, and supporting documentation for clinical evaluation activities.
  
• To keep updated with applicable regulatory and scientific requirements related to EU MDR, clinical evaluation, PMCF, PMS, and medical-device clinical evidence.
  

Preferred candidate profile

• Education: M.Sc. in Zoology, Life Sciences, Biotechnology, Microbiology, Biomedical Sciences, Pharmacy, or a related field.
  
• Experience: 02 years of 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.
  
• Good knowledge of scientific literature search and review.
  
• Familiarity with PubMed, Google Scholar, ClinicalTrials.gov, or similar scientific databases.
  
• Ability to understand and interpret scientific/clinical publications and research papers.
  
• Good scientific writing, analytical, and critical-review skills.
  
• Basic understanding of EU MDR 2017, particularly requirements related to clinical evaluation and clinical evidence, is preferred.
  
• Good command of English, particularly written English.
  
• Good attention to detail and ability to maintain accurate references and documentation.
  
• Ability to work with cross-functional teams and manage multiple documents/deadlines.
  
• Proficiency in MS Word, Excel, and PowerPoint.

Preferred candidate profile