Senior Regulatory Analyst

Bangalore, Karnataka
Permanent
Full-time

15 days ago

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 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 which makes everything possible.The Senior Regulatory Analyst (P3) 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)
Write 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.

The essential requirements of the job include:A Bachelor’s degree in areas of life sciences or engineering field with a minimum of 12-15 years’ experience in a regulated medical device/diagnostic industry (less years required with advanced degree).

Professional designations are not required but training and certificates in quality or regulatory affairs would be a plus (e.g. CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean)
Experience in supporting filing of pre-market regulatory submissions domestically (Q-Subs, 510ks) and internationally (IVDR; China; ROW Global Registrations).
Knowledge of domestic and international quality systems and other standards such as FDA QSR, IVDD/IVDR, INVIMA, ANMAT, ANVISA, COFEPRIS, ISO 13485, ISO 9001 and other applicable standards and regulations.
Knowledge of design control process requirements and requirements for technical documentation for in vitro diagnostics and or medical devices.
Experience with Software as a Medical Device (SAMD) and Software as an accessory to a device highly desirable.

Required Competencies:

Critical thinker able to address complex situations and issues.
Manages changing conditions, processes, and approaches; leads organizations through change effectively.
Ability to adopt a systemic view of process improvement and to advise process improvement teams to reach goals.
Organized and thorough with a high level of initiative, self-motivation and energy.
Quick adaptability to embrace company culture and flexibility to manage multiple projects at the same time.
Ability to participate in meetings outside of regular business hours to support global business.

It would be a plus if you also possess previous experience in:

Instrument and software development in the context of medical device

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 .This job is also eligible for bonus/incentive pay.Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.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 .

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