BD Career Opportunity for Regulatory Affairs Job in Bengaluru
This Regulatory Affairs Job is an excellent opportunity for professionals seeking growth in healthcare compliance and documentation management. The role combines regulatory operations, product registration support, and quality system coordination within a globally recognized healthcare environment. Inspired by the innovation-driven culture associated with BD career opportunities, this Chemistry Job offers exposure to medical device regulations, international compliance systems, and cross-functional collaboration for candidates aiming to build a successful regulatory career.
- Position: Regulatory Affairs Operations Analyst
- Location: Bengaluru, Karnataka
- Job ID: R-544104
- Category: Regulatory Affairs
About the Company:
BD is a leading global medical technology company dedicated to advancing healthcare innovation and improving patient outcomes. Through BD career opportunities, professionals gain experience in regulatory systems, medical technologies, and global compliance frameworks. The company supports collaborative work environments focused on quality, research, and operational excellence. It provides an ideal platform for candidates pursuing a Regulatory Affairs Job and seeking long-term professional growth within the healthcare and Chemistry Job sectors.
Job Overview:
This Regulatory Affairs Job is based in Bengaluru and focuses on regulatory documentation, product registration support, and compliance management activities. The role includes maintaining regulatory databases, supporting change management processes, and coordinating
with multiple departments for documentation updates. Candidates applying for this Chemistry Job will contribute to regulatory operations aligned with global medical device standards and healthcare quality requirements.Job Responsibilities:
- Identify, submit and maintain regulatory information in Regulatory databases.
- Manage Notification of Change (NoC) in RIM system. Create NoCs, route for region/country impact assessment, track RA project requirements, link evidence of completion, and complete final RA documentation for project closure.
- Support RIM system changes including system configuration decisions, workflow design, data migration, and on-boarding new users.
- Assess necessity for submitting a 510(k) application for proposed device changes. Prepare internal “Non-Filing Justifications” (U.S.) for changes that do not require a 510(k) submission.
- Assess necessity for notification to the Notified Body about significant changes to CE marked products in a timely manner. Prepare documentation updates for non-significant changes in a timely manner.
- Complete, review/approve documentation to ensure regulatory compliance.
- Coordinate and collect specific registration information with R&D, Manufacturing, QA, Medical, and other applicable departments as necessary to update Regulatory documentation.
- Submit regulatory information on products to external databases when deemed necessary.
- Responsible for writing and updating standard operating procedures (SOP), work instructions (WI), and policies on an as-needed basis.
- Coordinate and respond to requests for product data and information.
Education and Experience:
- Education: B.S. degree or higher in a technical discipline, preferably in chemistry.
- Experience: 2-4 years Regulatory Affairs experience in medical device companies including international product registrations, new product development, and sustaining engineering.
Knowledge:
- Working knowledge of 510(k) (for both medical devices), MDD 93/42/EEC, and working knowledge of 21 CFR 820 – Quality System Regulation and working knowledge of standards and FDA guidance’s.
- Working knowledge of all material related regulatory requirements (e.g., Prop 65, CONEG, DOT, IATA, IMO, OSHA, etc.) in the US, Europe, and Canada.
Skills:
- Proficient in using Microsoft Word, Excel, and PowerPoint.
- Proficient in English
- Strong communication skill, both oral and written
- Strong project management skills
- Must be able to handle multiple tasks and attention to detail.
- Self-motivated, comfortable with working with people remotely
- Organized, analytical thinker with attention to details.
This Regulatory Affairs Job offers a strong career pathway for candidates interested in compliance, healthcare regulations, and documentation management. With exposure to global quality systems and medical technology operations, the role provides excellent professional development opportunities. Aligned with the innovative and growth-oriented environment associated with BD career opportunities, this Chemistry Job is ideal for professionals seeking long-term advancement in the healthcare and regulatory affairs industry.
