Greetings!Hiring for the below position with a leading Medical Devices MNCRole: Specialist/ Sr. Specialist/ Assistant ManagerExperience: 7-12 yearsLocation: New DelhiSkills required:The ideal candidate would have a diploma/degree in a scientific discipline such as Biology,Microbiology, Pharmacy, pharmacology, Biotechnology, engineering, or medical technology.Minimum 5 years of experience in Medical devices regulatory affairs and 7-8 years of workingexperience in a Medical devices/Pharmaceutical company.Good working knowledge of MS-EXCEL and PowerPoint will be preferred.Working experience of Regulatory document management system (Agile, RIMS, Livelink etc.)Association or working experience in Central/State regulatory authority will be preferred.Job Description:Compile and review regulatory submissions for timely registration of new products & on-time renewalof registered products.Develop timelines, coordinate receipt of technical information from global RA and independentlyexecute new product registrations, change reporting and PAC submissions.Review technical documents before submission to external party and/or Health authority to ensure thedocuments meet and/or fulfil the country requirement/request. Ensure the documents are legalizedand/or notarized where required.Liaise with the necessary parties, consultants, distributors, internal TMI functions and other relevantstakeholders, to understand, evaluate the requirements and acting accordingly.Monitor and update registration activities and/or status to all relevant stakeholders on a regular basis.Ensure the required actions and responses are in place in a timely manner .Quick understanding and resolution of queries from Central/ State Licensing AuthorityDraft processes for new regulatory requirements under supervision of reporting manager towardseffective implementation of internal processes/policies.Provide timely intel to reporting manager in sending out key communication, internal documentmodification to ensure minimal/no impact to business .If interested kindly send your updated CV to [Confidential Information]RegardsAishwarya
