Responsibilities Thorough understanding of the global Clinical Evidence requirements for regulatory compliance in the European and Australian market. Understanding of Europe's new Medical Devices Regulation (MDR 2017/745) and the US FDA regulatory pathways for medical devices. Review analytical data from development studies and performance evaluation studies to ensure regulatory requirements are met. Completely review all existing documentation in support of meeting the applicable Essential Principles of the Regulation(s). Evaluate and identify gaps or deficiencies in documentation. Determine applicable testing requirements and standards for subject device. Review available clinical data, compile a comprehensive and compliant Clinical Evaluation Report (CER), and facilitate a Risk Assessment as necessary. Compile and/or review proposed labelling and Instructions for Use. Assess global regulatory requirements and make recommendations based specific regions to management to ensure technical documentation is compliant to introduce to global markets.   Qualification & Experience Tertiary qualifications such as an undergraduate science or engineering degree or equivalent. A minimum of 3+ years demonstrated success in the analysis and interpretation of regulatory documentation and technical writing. Thorough understanding of the requirements of the new European Medical Device Regulation (EU MDR) and some understanding of the Australian Medical Device Regulations. Extensive experience in Medical Writing and preparation of Clinical Evaluation Reports (CERs) Experience with preparing USA Premarket Notifications [510(k)s] (desirable) Excellent communication skills  

Responsibilities Europe/Australia/ Canada Drug Dossier Authoring, Reviewing & Submission drug product dossier application (EU/UK/AU/CA) Product life cycle management (LCM) activities Assessment ofpost approval changes eCTD publishing Thorough knowledge of CMC and Module 1 requirements Preparation & Submission Authoring and review & submission of new dossier application, variation, renewal and RFI for EU (DCP/MRP/NP), UK, Australia & Canada Health Authority Authoring of Module 1 along with quality modules Assessments of post approval changes, life-cycle maintenance and ensure timely post approval regulatory activities Coordinate with cross-functional teams for desired regulatory data and accordingly plan & complete regulatory filing activities Review and finalization of artwork/label as per current QRD guideline Regulatory Intelligence and develops up-to-date knowledge with regard to technical guidelines and regulatory requirements, as well as technical trends eCTD publishing Coordination Interface with R&D and other business functions on a regular basis to ensure project-specific regulatory strategy is met as agreed in timely manner Co-ordination with API vendors to resolve technical quires w.r.t. regulatory requirements To review technical documents like process validation, AMV, Stability and composition etc. received from Site QA or R&D/ADL against DMF/Dossier requirements Reporting & Maintenance Maintain regulatory files/database

Responsibilities Principle Accountabilities Case processing / data entry and related activities in the Argus safety database as per DE conventions within specified timelines. Participate in downloading, triaging, uploading and book-in of regulatory and EMA MLM ICSR reports. Participate in triaging and book-in of literature reports. Triage, Case book-in, data entry & archiving. Ensure use of PV-MedDRA for coding adverse reactions Documentation Ensure that pharmacovigilance SOPs, procedures, processes, and guidelines are adhered to communicate with external and internal customers in a timely manner, as per the requirement. Statutory Compliances Maintain an awareness of current legislation associated withthe Worldwide Regulatory Pharmacovigilance requirements. Ensures regulatory compliance by providing timely, quality information for aggregate reports and signal review following SOPs and regulations.  

Qualification & Experience MBBS 2-5 years of experience.   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Qualification & Experience GNM / BSC 5-10 years of experience in ICU/Ward/ER and HDU.   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Qualification & Experience Medical Degree (MBBS) with a Master's in Hospital Administration (MHA) or an equivalent Degree 4-10 years of experience in hospital administration, with a focus on patient care and quality improvement   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Qualification & Experience Bachelor's in Medicine from an accredited institution 2-5 years of experience   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Qualification & Experience Master's in Occupational Therapy 3+ years experience providing Occupational Therapy   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Qualification & Experience MHA With 4 years’ experience in Quality Department can apply   Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"  

Qualification & Experience MBBS 0-1 years of experience Note: Please ensure you include this in the EMAIL Subject line: "medbots.in: YourName: Years  of Experience"