Regulatory Documentation Specialist

2 weeks ago

pushkar, India beBeeMedical Full time

Job DescriptionSeeking a skilled Medical Writer to create, update, and manage regulatory and clinical documents for medical device projects.This is a full-time site-based role on a 12-month fixed-term contract with potential for extension. The successful candidate will work in a dynamic scientific operations team supporting medical device projects.Responsibilities:Create, update, and manage Clinical Evaluation Reports (CERs), Summary of Safety and Clinical Performance Reports (SSCPs), State of the Art Reviews (SOAs), and Systematic Literature Reviews (LRRs) within assigned therapeutic areas.Participate in all core steps of systematic literature reviews, including search, screening, data extraction, analysis, and synthesis.Summarize clinical, non-clinical, and regulatory data to perform risk/benefit analyses on medical devices.Compare device safety and performance against the state of the art and investigate unexpected outcomes.Utilize various software systems, including Microsoft Office, EndNote, Distiller, Wrike, and in-house AI tools, to create required documents.Follow company procedures, regulatory guidelines, and health, safety, and environmental practices.Collaborate with cross-functional teams, including Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs.Communicate business-related issues or opportunities effectively.Requirements:Bachelor's degree in a relevant field, such as life sciences, biology, or English; advanced degree preferred.Minimum of 3 years' experience in medical writing or related roles.Experience in the medical device industry and knowledge of CER regulatory requirements, evidence generation, and literature reviews preferred.Familiarity with clinical research, quality/regulatory compliance, and adverse event reporting is a plus.Strong oral communication, presentation, project management, and prioritization skills.Additional Qualifications/Desirable:Background in life sciences (Dentistry, Optometry, Veterinary Science, etc.) welcomed.Experience with CER creation, MEDDEV 2.7.1 rev 4, MDCG/MDR regulations considered a strong advantage.Proven ability to perform literature searches, summarize clinical conditions, and assess risks and benefits for medical devices.Experience reviewing supporting device documentation and analyzing device performance data.This is an exciting opportunity for a detail-oriented professional to contribute to regulatory and scientific documentation within the medical device sector while working in a collaborative, cross-functional environment.

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