Are you ready to accelerate your potential and make a real difference within life sciences diagnostics and biotechnology At Cepheid one of Danaher s 15 operating companies our work saves lives and we re all united by a shared commitment to innovate for tangible impact You ll thrive in a culture of belonging where you and your unique viewpoint matter And by harnessing Danaher s system of continuous improvement you help turn ideas into impact - innovating at the speed of life At Cepheid we are passionate about improving health care through fast accurate molecular diagnostic systems and tests As a member of our team you ll get to make an immediate measurable impact on a global scale within an environment that fosters career growth and development Our mission drives us to develop groundbreaking solutions for the world s most complex health challenges Together we bring MORE change to the world Learn about the Danaher Business System which makes everything possible The Regulatory Affairs Specialist is responsible for supports the On-Market Sustainment Team by preparing global change notifications and updating technical documentation to maintain product approvals This role is responsible for compiling and supporting regulatory submission packages across affected regions ensuring compliance with local regional and global requirements The specialist also contributes to planning activities supports internal audits and inspections and stays current with evolving regulatory policies Additionally the role involves training cross-functional teams and assisting with post-market regulatory activities This position is part of the Global QRC On-market Sustainment team and will be an on-site role in Bengaluru India In this role you will have the opportunity to Create update and maintain regulatory documentation and controlled files in compliance with global IVD and medical device regulatory standards Prepare and deliver documentation packages for change registrations of Cepheid products including required technical and regulatory artifacts Identify track and apply local regional and global regulatory requirements using validated regulatory intelligence sources and databases Assess regulatory changes for impact on product lines and associated functional areas documenting applicability and required actions Compile complete materials for regulatory submissions license renewals annual registrations and internal regional regulatory reports The essential requirements of the job include Master s degree with 2 years of related experience or Bachelor s degree with 5 years of experience in regulatory compliance or quality functions at a medical device or IVD manufacturing site Demonstrated regulatory or scientific knowledge applicable to medical device or IVD manufacturing environments Experience interpreting complex regulatory requirements and applying them to operational or compliance activities Proven ability to address ambiguous regulatory or compliance issues and recommend appropriate actions within a regulated manufacturing setting Ability to meet physical and operational requirements including defined travel expectations valid driver s license with acceptable driving record and capability to lift move or carry equipment up to 25 lbs It would be a plus if you also possess previous experience in Knowledge of Global IVD regulations and CE-IVDR a plus Prior knowledge of different databases like SAP Agile Trackwise etc is preferred Quality Control Quality Systems Assurance Compliance Cepheid a Danaher operating company offers a broad array of comprehensive competitive benefit programs that add value to our lives Whether it s a health care program or paid time off our programs contribute to life beyond the job Check out our benefits at Danaher Benefits Info This job is also eligible for bonus incentive pay We offer comprehensive package of advantages including paid time off medical dental vision insurance and 401 k to eligible employees Join our winning team today Together we ll accelerate the real-life impact of tomorrow s science and technology We partner with customers across the globe to help them solve their most complex challenges architecting solutions that bring the power of science to life For more information visit www danaher com