Compliance and Audit Executive (Medical Devices)

Job Description

Job Description for the Role of Compliance and Audit Executive (Medical Devices ) Location: Ambarnath Band: 5B Salary: 30K to 50K Responsibilities: 1.Collaborate with various departments to ensure compliance with MDR(India) 2017, EUMDR 2017/745, ISO 13485:2016, ISO 9001:2015 and another relevant applicable regulatory requirement as and when enforced / implemented. 2.Review and improve existing SOP, Work Instructions, Policies and QMS Forms across departments to comply the above said standards. 3.Preparation and Compilation of Technical documents/Device Master File according to the above said standards. 4.Strong understanding in performing Risk Management Process as per ISO 14971. 5.Good Knowledge in conducting Process Validation, Design Control and Software Verification and Validation activities. 6.Governing the import, manufacture, distribution, and sale of medical devices in India. 7.Conduct internal audit and to support external audit to ensure the compliance with the applicable standards. 8.Able to handle post-market surveillance and complaint handling process. 9.Understand RCA techniques and perform CAPA as and when required. Education and Experience: 1. Bachelors degree in a relevant field such as Science/Engineering Biomedical, Electronics, Mechanical etc. 2. Individuals with up to 2+ years of experience in regulatory compliance or medical device industry are welcome to apply. 3. Having certificate of ISO 13485 Internal Auditor / Lead Auditor is added advantage. 4. Strong analytical skills and the ability to interpret complex regulatory information. 5. High IQ with a demonstrated aptitude for understanding and applying regulatory standards.