Senior Regulatory Analyst Radiometer Medical

12.0 - 15.0 years

11 - 16 Lacs

bengaluru

Work from Office

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.

Posted 10 hours ago

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