Regulatory Affairs Manager

Job Description

Senior Regulatory Affairs Manager The Senior Regulatory Affairs Manager will be responsible for supporting international regulatory affairs registrations of medical devices across the globe. Job Description This position involves the creation, identification, collection, and entry of regulatory affairs information related to medical devices. The role includes supporting international regulatory submissions, managing country registration requests, and ensuring compliance with global regulatory requirements. The position requires strong organizational skills, effective communication, and the ability to manage multiple tasks efficiently . Essential Responsibilities Create, submit, and maintain product registration requests for submission. Develop, submit, and manage EU MDR, MDSAP, and EN ISO 13485 documents for regulatory compliance. Review and approve submission documents to ensure compliance with regulatory standards. Maintain up-to-date metrics with product registration requests and submission schedules. Track and monitor regulations applicable to medical devices in designated countries. Manage and update internal regulatory databases, including licenses and registration records . Qualifications Educational Background B.S. degree or higher in a technical discipline, preferably in Computer Science, Engineering, Bioengineering, Biology, or Chemistry . Professional Experience 3-7 years of Regulatory Affairs experience in the medical device industry , including international product registrations and new product development. Knowledge and Skills Knowledge: Working knowledge of 510(k) submissions, EU MDR 2017/745, MDSAP, EN ISO 13485, and 21 CFR 820 - Quality System. Skills: Proficient in Microsoft Word, Excel, and PowerPoint. Strong communication skills (oral and written) in English. Excellent project management skills. Ability to manage multiple tasks with strong attention to detail. Self-motivated and comfortable working remotely with international teams. Organized and analytical thinker with problem-solving abilities.  Primary Work Location: Valsad, Gujarat