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    Regulatory Compliance Specialist - Bangalore, India - Danaher Corporation

    Danaher Corporation
    Danaher Corporation Bangalore, India

    1 month ago

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    Paid Work
    Description

    #LI-VK1

    Be part of something altogether life-changing

    Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.

    At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term.

    Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.

    The Regulatory Compliance Specialist for Cytiva is responsible is part of the Quality and Regulatory Affairs team located in Bangalore and will be Hybrid in nature. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.

    In this role, you will have the opportunity to:

    • Support the development of new products within the Cytiva business with focus on chemistry.
    • Core team member for New Product Development (NPD) projects to secure compliance to relevant regulations to get market access
    • Review change requests/orders to ensure that Compliance requirements are met and maintained.
    • Maintain awareness of applicable regulations, and monitor activities related to changes to regulations.
    • Participate/support Project Management Office (PMO) projects The essential requirements of the job include:
    • Bachelors' Degree in electrical and/or mechanical engineering or related discipline
    • Experience with Product regulations, QA/RA, other regulatory areas or experience with Cytiva's product portfolio and an interest to learn about regulatory compliance. It would be a plus if you also possess previous experience in:
    • Knowledge around the Cytiva portfolio
    • Knowledge around environmental, chemistry and hardware regulations, e.g.
    • EMI/EMC, machinery directive, low voltage directive, product safety standards, CLP regulations, safety data sheets.
    • CE marking, NRTL marking (UL, TUV, ETL)
    • REACH/ROHS and other restricted substances framworks
    • Experience with authorities and testing institutes, e.g. Intertek, TUV. At Cytiva 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 Cytiva can provide.

    At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit

    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.


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