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Assistant Manager- Regulatory Affairs

3.00 to 5.00 Years   Gurgaon (Haryana)   14 May, 2025
Becton Dickinson India Pvt Ltd
Job LocationGurgaon (Haryana)
EducationAny Graduate
SalaryAs per Industry Standards
IndustryHealthcare, Biotechnology/Pharmaceutical/Medicine
Functional AreaIT Software : Software Products & Services
EmploymentTypeFull-time

Job Description

SummaryDossier lifecycle management, import license filing preparation and submission, Maintenance of database, Labeling review as per MDR 2017 and Legal metrology, RIM, cross functional collaboration.We are the makers of possibleBD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and its no small feat. It takes the imagination and passion of all of usfrom design and engineering to the manufacturing and marketing of our billions of MedTech products per yearto look at the impossible and find transformative solutions that turn dreams into possibilities.Why Join UsA career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, youll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.Become a maker of possible with us!ResponsibilitiesTo assist in the analysis and improvement of existing regulatory processes through regulatory activity immersion. Key responsibilities will include:

  • Support regulatory efforts required to comply with new and existing regulations (e.g., FDA Medical Device Regulations and Guidelines, MDSAP) and other requirements including changes to FDA guidelines and applicable international standards
  • Leading efforts for UDI including US, EU, and International requirements
  • Support efforts for Technical File creation and remediation, collaborating with cross-functional teams for required content
  • Support regulatory impact assessments for change controls and other RA/QA items
  • Collect, store, and maintain regulatory documentation and assists in managing the data structure of the regulatory network (PIM, DMS, etc.)
  • Proven ability to interpret medical device Quality System Regulations
  • Assists in preparing, auditing, editing, and publishing registration documentation, as needed
  • Support business export control (BEC) listing of product for release globally per RA requirements
  • Support the review and approval of product labeling, promotional, and advertising materials as needed
  • Performs other duties and assignments as required
Click on apply if this sounds like you!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.To learn more about BD visit: https://bd.com/careersRequired Skills(Optional Skills)Primary Work LocationIND Gurgaon - Signature Towers BAdditional LocationsWork Shift Locations - Onsite

Keyskills :
regulatory compliance quality system regulations technical file creation dossier management cross functional collaboration database pim

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