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Regulatory Affairs Analyst

Min Experience

8 years

Location

Bangalore, Karnataka, India

JobType

full-time

About the job

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About the role

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Beckman Coulter Life Sciences, 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 Beckman Coulter Life Sciences, we know time is the most critical facet in the laboratory today: time to get life-saving therapies to patients faster; reclaiming time by automating tedious manual workflows; and saving time spent addressing erroneous or complex results. We are partners in time and accelerate answers to critical questions through the power of automation. We develop innovations for scientists by scientists, with many of our 3,300+ global colleagues coming from the laboratory. It's all part of our time-tested approach to bringing meaningful innovations at the speed of life since 1935. And we're just beginning. Working together, let's put our time and talents together to advance human health for tomorrow. Learn about the Danaher Business System which makes everything possible. The Regulatory Affairs Analyst is part of an international team responsible for supporting global registrations for reagent, instrument and software products, new product development, advertising and promotional materials, product labeling, post market regulatory compliance and adapting to new/changing regulatory requirements. This position reports to the Global Regulatory Manager and is part of the LS Global Regulatory affairs Team located in Bangalore and will be an on-site role. In this role, you will have the opportunity to: Perform registration dossier for all the Life Science Products in all countries (except USA) Participate to gathering the technical documentation for new product development Maintain the adequacy with the regulation for technical documentation Product lifecycle management: Support product design changes, labeling updates, sustainment, and improvement activities from regulatory perspective. Assess regulatory impact, develop detailed action plan to drive regulatory compliance and ensure on time completion of identified actions.

About the company

Beckman Coulter Life Sciences, 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.

Skills

regulatory affairs
medical device
diagnostics
quality systems
regulatory compliance
product lifecycle management
technical documentation