Job Title Regulatory Affairs Program Manager The Regulatory Affairs Program Manager will be responsible for Providing Regulatory Technical Competency tactical and strategic to the AM D business group including providing accurate and consistent regulatory recommendations decisions and feedback to product development and manufacturing teams and preparing comprehensive regulatory strategies for current devices and significant post market changes Assess product changes for impact on global regulatory registrations ensuring continued compliance with applicable regulations Create detailed written regulatory plans that can be used to support international regulatory submissions and global product sales Develop and prepare product registration submissions for the US Canada EU and support submission preparation for additional regulated markets Review and approve advertising promotional items and labeling for regulatory compliance Perform regulatory impact and regulatory compliance evaluations to support engineering changes and post market activities Identify potential regulatory approvals risks based on changes in regulations standards country specific issues or other unique characteristics of the project Keep abreast of current regulatory standards procedures and changes Following Quality System procedures to ensure compliance with US CFR ISO 13485 MDD MDR CMDR MDSAP and all other applicable regulations and drive improvement in regulatory aspects of the Quality System developing processes and documenting procedures to ensure an effective Quality System Review and recommend changes for design process and manufacturing procedures to maintain quality and regulatory compliance Additionally the Regulatory Affairs Program Manager will Communicate effectively with internal stakeholders Collaborate with worldwide colleagues regarding license renewals and updates Maintain regulatory files and tracking databases as required Support the audit team as subject matter expert To succeed in th

📌 Regulatory Affairs Program Manager (Bengaluru)
🏢 Philips
📍 Bengaluru