Assistant Manager- Regulatory Affairs
3 days ago
Summary Dossier lifecycle management import license filing preparation and submission Maintenance of database Labeling review as per MDR 2017 and Legal metrology RIM cross functional colloboration We are the makers of possibleBD is one of the largest global medical technology companies in the world Advancing the world of healthxe2x84xa2 is our Purpose and its no small feat It takes the imagination and passion of all of usxe2x80x94from design and engineering to the manufacturing and marketing of our billions of MedTech products per yearxe2x80x94to 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 ResponsibilitesTo 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 Required SkillsOptional Skills Primary Work Location IND Gurgaon - Signature Towers BAdditional LocationsWork Shift
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