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BD (Becton, Dickinson and Company) Senior Regulatory Affairs Specialist in Bengaluru, India

Job Description Summary

Be part of something bigger!

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

In BD Specimen Management (SM), we develop some of the most widely used products in the field of specimen collection including acquisition of the sample, collection into an appropriate container, and also emerging point-of-care applications. Our team has the unique opportunity to be involved with both medical devices and in vitro diagnostics, allowing you to broaden your expertise and grow in your career. Our Senior Regulatory Affairs Specialist position is primarily focused on leading standards and evolving regulations compliance activities for the SM organization, which is critical to maintaining continued market access of our existing product portfolio. The ideal candidate will be energetic, possess a strong project management background, understand standards and regulations compliance as part of regulatory compliance, and perform well independently and as part of a team.

Our people make all the difference in our success. Join us in our mission to advance the world of health.

Job Description

  • Represent RA and demonstrate leadership in standards and regulations compliance by identifying and interpreting relevant requirements, and providing actionable strategies for implementation.

  • Lead regulatory efforts required to comply with new regulations (e.g., EU MDR/IVDR, MDSAP) and other requirements including changes to international standards.

  • Develop and maintain standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards.

  • Lead/participate in regulatory standards and regulations development/compliance activities as necessary to support BD’s continuous product development and compliance efforts.

  • Remain current on regulations/standards affecting BD products and keep the relevant team and supervisors informed about potential impact.

  • Identify ways to improve the efficiency of current work processes and execute them.

  • Assist with updates to Technical/STeD files and standard operating procedures associated with timely implementation of updated regulations/standards.

  • Partner with the central Regulatory Affairs Intelligence team on evolving standard and regulatory requirements interpretation and implementation specific to SM.

  • Regularly report findings to cross-functional SM stakeholders and contribute to regulatory intelligence implementation.

  • Carry out the above tasks with limited supervision.

Primary Work Location

IND Bengaluru - Technology Campus

Additional Locations

Work Shift

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.