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| Job Location | Mumbai City |
| Education | Not Mentioned |
| Salary | Rs 5 - 10 Lakh/Yr |
| Industry | IT - Software |
| Functional Area | Sales / BD |
| EmploymentType | Full-time |
Designation: Post Sales Regulatory Affairs Specialist for Medical Devises, Kurla, Mumbai Work Experience: 5+ Year Experience Number of Positions: 2 Place of Posting: Kurla Mumbai Industry: Medical Device MNC Company Salary: Up to Rs. 10.0 Lac Key Role & Responsibilities: Responsible for post market product compliance, including but not limited to the medical devices for Advanced Sterilization Products (ASP) and disinfectants. Reviews the international labeling for accuracy and compliance with regulations for the imported products. Participate and support the post-market audits Review and submit promotional materials to health authorities to get approval. Coordinates post-market random tests requested by health authorities. Responsible for the medical device GSP filing and approval. Support analysis/ activities/ communications from RA perspective on product complaints, adverse events, and field actions, etc. Other post-market product compliance relevant tasks. Key Skills: Regulatory Affairs for Medical Devises, Advanced Sterilization Products & Disinfectants, Review International Labeling & Compliance, Imported Medical Devices, Post Market Audit, Liaison Health Authorities, GSP Filling & approval,Required Candidate profileEssential Education, Experience & Skills: BSc in bioscience or a comparable combination of education and 3+ year experience in Regulatory Affairs in Medical Devises Company dealing with Advanced Sterilization Products (ASP). Prior experience in post-market in MNC medical device company is essential. Hands-on experience with/ participation in Regulatory Authority Inspection/Audit for imported Medical Devices for Advanced Sterilization Products (ASP). Strong learning ability, team player. Good communication and inter-personal skills. Good in spoken & written English. Key Skills:Regulatory Affairs for Medical Devises, Advanced Sterilization Products & Disinfectants, Review International Labelling & Compliance, Imported Medical Devices, Post Market Audit, Liaison Health Authorities, GSP Filling & approval, ,
Keyskills :
post salesadverse events medical devicescorporate liaison regulatory affairsproduct compliance product complaintscontrolled envi