Regulatory Affairs Manager

Job Description

#Hiring Regulatory Affairs Manager for one of the reputed MNC into Healthcare industry. Position Title: Regulatory Affairs Manager Location: Gurugram About Role:- The Regulatory Affairs Manager will be responsible for managing the regulatory strategy and ensuring the compliance of medical devices/IVD with applicable regulations. The candidate should have relevant years of experience in Regulatory Affairs. Preferably, complete knowledge of Indian Regulatory Requirements with in-depth understanding of D&C Act, MDR 2017& BIS. This role involves working closely with cross functional team. The manager will monitor regulatory changes, support product submissions, and ensure timely approvals to maintain product marketability in India. Key Accountabilities:- Provide Regulatory Support for timely new product launches. Well versed with filing application of Import Registration/Import license/Test License on SUGAM portal and NSWS & BIS Regulations & Certification. Stay abreast of regulatory procedures and changes in regulatory climate. Responsible for managing BIS application and submission procedures To review Medical Device dossier and technical documents to support country specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents and take appropriate actions to obtain regulatory approvals as planned. Address queries from CDSCO/NSWS on submitted applications, provide regulatory support and assist in preparing a response to regulatory authoritys questions within assigned timelines. Responsible for managing modifications to a device after it has received regulatory approval. Work with other departments and communicate the submission requirements when documents are needed for regulatory submission. Timely tracking and reconciliation of routine submissions/activities/Query response Post-Market Surveillance: Manage post-market surveillance activities, including adverse event reporting, field safety corrective actions, and vigilance reporting. Minimum Knowledge & Experience required for the position: Bachelor's/ Masters degree in a relevant field, such as life sciences, or regulatory affairs. Around 5+ years of relevant experience in Healthcare Industry (Medical Devices/IVDs) in Regulatory Affairs (MNCs) is desirable. Skills & Capabilities: Hands-on experience with the NSWS/ SUGAM portal and CDSCO online submission process. Strong understanding of Indian regulatory frameworks including CDSCO & BIS. Attention to detail and critical thinking skills Ability to work collaboratively with cross-functional teams. Note:- Looking Male candidate with decent exposure into RA role with reputed MNC's. If above role matches with your experience & aspirations than share CV to: recruit.corp12@apexservices.in