Expert Medical Writer

2 days ago

hubballi, India beBeeRegulatory Full time

Job OverviewWe are seeking a detail-oriented professional to contribute to the creation of regulatory and scientific documentation within the medical device sector.This is an exciting opportunity for someone with expertise in medical writing to join our dynamic team and play a key role in supporting medical device projects.About the RoleThe successful candidate will be responsible for creating, updating, and managing a range of regulatory and clinical documents including Clinical Evaluation Reports (CERs), Summary of Safety and Clinical Performance Reports (SSCPs), State of the Art Reviews (SOAs), and Systematic Literature Reviews (LRRs) within their assigned therapeutic area.Write and update CERs, SSCPs, SOAs, and LRRs in compliance with applicable regulatory requirements and guidelinesParticipate in all core steps of systematic literature reviews, including search, screening, data extraction, analysis, and synthesisSummarize clinical, non-clinical, and regulatory data to perform risk/benefit analyses on medical devicesCompare device safety and performance against the state of the art and investigate unexpected outcomesThe ideal candidate will have a strong understanding of regulatory requirements and guidelines, as well as excellent communication and project management skills.RequirementsTo be considered for this role, candidates must have:A BA, BS, or BSN degree; advanced degree preferredMinimum of 3 years' experience in medical writing or related rolesExperience in the medical device industry and knowledge of CER regulatory requirements, evidence generation, and literature reviews preferredCandidates with a background in life sciences, experience with CER creation, and familiarity with MEDDEV 2.7.1 rev 4, MDCG/MDR regulations will be highly regarded.BenefitsThis is an excellent opportunity to work in a collaborative, cross-functional environment and contribute to the success of our medical device projects.

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