Senior Regulatory Document Specialist
2 weeks ago
Job OverviewWe are seeking a detail-oriented Medical Writer to create and manage regulatory and clinical documents in the medical device sector.Key Responsibilities:Write and update Clinical Evaluation Reports (CERs), Summary of Safety and Clinical Performance Reports (SSCPs), State of the Art Reviews (SOAs), and Systematic Literature Reviews (LRRs).Participate in 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 software systems, including Microsoft Office, EndNote, Distiller, Wrike, and in-house AI tools.Requirements:BA, BS, or BSN required; 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.Strong oral communication, presentation, project management, and prioritization skills.Additional Qualifications:Background in life sciences welcomed.Experience with CER creation, MEDDEV 2.7.1 rev 4, MDCG/MDR regulations considered a strong advantage.Benefits:This is an exciting opportunity for a professional to contribute to regulatory and scientific documentation within the medical device sector while working in a collaborative environment.
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Regulatory Content Specialist
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tiruchirappalli, India beBeeMedicalWriter Full timeJob OpportunityWe are seeking a skilled Regulatory Medical Writer to join our team.Responsibilities:Draft, review, and finalize regulatory documents such as clinical study reports and investigator brochures.Conduct literature reviews, adhere to regulatory guidelines, collaborate with cross-functional teams, and ensure accurate scientific communication.Key...
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Documentation Specialist
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Global Regulatory Affairs Professional
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tiruchirappalli, India beBeeRegulatory Full timeJob Title: Regulatory Affairs Specialist –Regulatory Submissions & ComplianceAuthor, compile, and submit regulatory dossiers to global health authorities, including USFDA, EMA, MHRA, TGA, HSA, NPRA, Thai FDA, Taiwan FDA, CDE, NMPA, PMDA, and others.Conduct dossier gap analysis to identify document and data gaps across all CTD modules (1–5).Convert and...
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Technical Documentation Specialist
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tiruchirappalli, India beBeeDocumenter Full timeTechnical Documentation SpecialistWe are seeking a seasoned Technical Documentation Specialist to create high-quality documentation that effectively communicates complex information to our audience.Main Responsibilities:Create and maintain technical documentation, including user manuals, API guides, release notes, and product-related materials.Collaborate...
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Senior Regulatory Affairs Associate
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tiruchirappalli, India beBeeRegulatoryAffairs Full timeJob DescriptionWe are looking for a highly experienced professional to fill the role of Senior Regulatory Affairs Associate.The ideal candidate will possess 3+ years of experience handling new registrations, life cycle management, renewals of Biologicals, Vaccines, recombinant protein molecules, monoclonal antibodies, plasma derived and small molecules in...
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Senior Consolidation Specialist
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Regulatory Affairs Specialist –
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Tiruchirappalli, India vueverse. Full timeKey Responsibilities:Regulatory Submissions & ComplianceAuthor, compile, and submit regulatory dossiers to global health authorities, including USFDA, EMA, MHRA, TGA, HSA, NPRA, Thai FDA, Taiwan FDA, CDE, NMPA, PMDA, and others.Conduct dossier gap analysis to identify document and data gaps across all CTD modules (1–5).Convert and prepare dossiers in...
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International Regulatory Affairs Specialist
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tiruchirappalli, India beBeeRegulatory Full timeSphera is a leading global provider of enterprise software and services that enables companies to manage and optimize their environmental, health, safety and sustainability. Our mission is to create a safer, more sustainable and productive world.We are guided by our core values of Customer Centricity, Accountability, Bias to Action, Innovation, and...
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Senior Document Preparation Expert
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tiruchirappalli, India beBeeDtp Full timeJob Opportunity:We seek an experienced DTP Specialist with advanced expertise in document formatting, graphic editing, and automation tools. The ideal candidate should have a strong background in the translation and localization industry and be capable of guiding junior team members.The successful candidate will be able to handle complex projects while...
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Senior Anesthesia Care Specialist
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tiruchirappalli, India beBeeAnesthesia Full timeJob DescriptionWe are seeking a dedicated Anesthesia Care Specialist to assist senior anesthesiologists in various surgical specialties.The role involves administering anesthesia, providing perioperative care, and performing ICU procedures as needed.Assist senior anesthesiologists in Neurosurgery, Urology, General Surgery, and other surgical...
