Job Description Summary

Our Senior Regulatory Affairs Specialist position is primarily focused on supporting regulatory sustaining activities within the SM organization, including providing support for change control activities and continued compliance with postmarket MDR and IVDR regulatory requirements.   The ideal candidate will be energetic, possess strong regulatory technical knowledge (particularly in the area of change control), have experience supporting MDR and IVDR requirements, and perform well independently and as part of a team. 

Job Description

P3-14314

Job 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 supporting regulatory sustaining activities within the SM organization, including providing support for change control activities and continued compliance with postmarket MDR and IVDR regulatory requirements.   The ideal candidate will be energetic, possess strong regulatory technical knowledge (particularly in the area of change control), have experience supporting MDR and IVDR requirements, 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 Responsibilities:(Primary Duties, Roles, and/or Authorities)

• Support the Regulatory Affairs function on Product Lifecycle Management (PLM)/Sustaining project teams and liaise with Regulatory Affairs subject matter experts (SMEs) to fulfill US FDA and EU CE requirements.
• Assist in compiling, drafting and submitting the required submission documents to support 510(k) and/or CE Technical File Documentation, (eg STeD ) to obtain clearances and/or approvals to established timelines.
• Assist and manage Notification of Change (NOC)/International Regulatory Affairs assessments of PLM/Sustaining activities to ensure regional/country requirements of US, EU and Rest of World (ROW) are captured in Regulatory strategy development.
• Develop regulatory strategies for Change Controls (CC) and establish Regulatory Requirements.
• Monitor completion of all CC task requirements recorded in the PEGA CC system and verify completion of requirements before Engineering Change Release ECRO release.
• Monitor and assess the impact of existing, modified and new standards pertaining to BD products for the US and EU markets and maintenance of related regulatory documentation.
• Support regulatory efforts to maintain and /or simplify technical documentation maintenance, labeling changes/remediations projects and UDI assessments.
• Review and approve labeling and promotional material for compliance to FDA and EU regulations.
• Support completion of EU Substantial Change Notifications and Substantial Change Applications for approval.  Prepare responses to notified body inquiries. 
• Prepare EU CE re-certification applications following notified body templates with supporting evidence from cross functional teams.
• Provide training or deliver presentations to cross-functional groups across TCI and SM on salient regulatory topics.
• Recognize potential compliance problems areas or associate ambiguity and make recommendations to resolve.
• Work independently and carries out the above tasks with minimal supervision.

Education and Experience:

• B.S. degree in a scientific, health sciences or technical discipline (e.g., engineering, bioengineering, biology, chemistry).  
• Minimum 5 years regulatory experience and working knowledge in regulated medical device or in vitro diagnostic device companies or an equivalence combination of experience with an advanced degree.
• Experience in preparing, approving and maintaining Technical Documentation and other submissions compliant with US, EU and global regulations
• Experience in supporting product development projects for product and process changes
• Demonstrated ability to participate on cross-functional team to consistently to meet regulatory requirements and project timelines. 

• Proficient in using Microsoft Word, Excel, PowerPoint, and Project. 
• Strong communication (written, oral) and project management skills. 
• Able to handle multiple competing tasks with great attention to detail. 
• Able to work independently to achieve objectives on or before schedule. 
• Demonstrated cross-functional collaboration and teamwork skills including influencing without authority. 
• Comprehensive knowledge of medical device regulations and standards. 
• Current knowledge of European quality system standards, and requirements under EU MDR and IVDR preferred. 
• Ability to navigate ambiguous regulatory requirements and standards interpretation. 

Primary Work Location

IND Bengaluru - Technology Campus

Additional Locations

Work Shift