Job Description

In our line of work, life isn\'t a given - it\'s the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world we\'re located. Creating impactful innovations like ours, doesn\'t happen overnight - it requires uncompromising persistency, passion, and a desire to make a difference. Here, you can learn, grow, and chart an uncommonly diverse career. Radiometer is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we\'re working at the pace of change to improve patient lives with diagnostic tools that address the world\'s biggest health challenges. Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries. A globally diverse team of 71,000 associates, we are united by our culture and operating system, the Danaher Business System, which is our competitive advantage. At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We\'re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you\'ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team. The position of RA Specialist for Radiometer is responsible for International registration by preparation (including testing, if needed) and timely submission of registration documents in India and other Asian countries to obtain approvals. Monitor Legislation and being able to translate this and implement this in Radiometer by review of the content of regulatory documentation related to relevant regulatory Guidelines Review and maintain Regulatory documents (including product label, promotional materials, manufacturing change requests, and registration packages, record product filings, approvals, and registration activities Execute plans, complete tasks according to priorities, align work with business goals, and align actions with agreed strategies Maintain strong relations with Internal and external stakeholders to ensure proper stakeholder management Support cross-functional projects and evaluate product changes and preparing regulatory strategies Participate in process improvements and creation of SOPs in the RA area Country Specific Labelling by participation in meetings and support to projects. Ensuring compliance of labelling (labels, IFUs, inserts, Manuals) for our products according to Indian RA requirements. Gather regulatory intelligence that is relevant to Radiometer portfolio and disseminate as appropriate This position is part of the Regulatory Affairs at Radiometer India Development Center located in Bengaluru, India and will be working in hybrid mode. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses. You will be a part of the Radiometer Regulatory Affairs Team and report to the Manager Regulatory Affairs at India Development Center. If you thrive in a multidimensional role and want to work to build a world-class Regulatory Organization-read on. In this role, you will have the opportunity to: Get exposed to Global Regulatory requirements Work on multiple Medical device documents and the DBS Learn and implement requirements of Regulations and Licensing as an Importer of a Medical Device. The essential requirements of the job include: 5-8 years of working experience in Regulatory Affairs in Medical Devices, ideally in IVDs. in a multi-function team environment. BE/BTech in engineering, Medical / Bio Medical or other science related field. Or equivalent. Has a proven track record of compiling regulatory files and achieving approvals Knowledge of international regulatory legislation. Experience with work relations in different cultures and ability to multi-task and prioritize competing demands Strong technical knowledge of medical products and terminology It would be a plus if you also possess previous experience in: Regulatory submissions for India and Asian countries. Experience with labelling requirements of medical devices and IVD medical devices. At Radiometer we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Radiometer can provide. When you join us, you\'ll also be joining Danaher\'s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you\'ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful tools and the stability of a tested organization. At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve.Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes. If you\'ve ever wondered what\'s within you, there\'s no better time to find out.

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