Regulatory Affairs Analyst at BD: Explore an Exciting Career Path

Regulatory Affairs Analyst Job – at BD, Apply Now!

Are you looking to advance your career in regulatory affairs? BD (Becton, Dickinson and Company) is hiring a Regulatory Affairs Analyst at its Technology Campus in Bengaluru, India. This role involves managing regulatory information for medical and in-vitro diagnostic devices while ensuring compliance with global standards like 510(k) and CE marking. With an opportunity to collaborate across departments and play a pivotal role in product compliance, this position offers a rewarding pathway for experienced regulatory professionals.

Job Description

Essential Responsibilities:

• Identify, submit and maintain regulatory information in Regulatory databases
• Support assessment for necessity to submit 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.
• Prepare technical files for CE marking of medical devices and in-vitro diagnostic devices with appropriate input from various functions (R&D, Quality, Manufacturing, etc.) in a timely manner.
• Review and approve labeling to ensure regulatory compliance in a timely manner.
• Complete, review, and approve documentation to ensure regulatory compliance required for Regulatory Affairs Analyst Job
• Coordinate and collect specific registration information with R&D, Manufacturing, QA, Medical and other applicable departments as necessary.
• Coordinate and respond to requests for product data and information.
• 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.

Qualifications:

Educational Background: 

B.S. degree or higher in a technical discipline, preferably in computer science, engineering, bioengineering, biology, or chemistry preferred for Regulatory Affairs Analyst Job.

Professional Experience: 

3 – 8 years Regulatory Affairs experience in medical device companies including international product registrations, new product development and sustaining engineering.

Knowledge and Skills

Knowledge

• Working knowledge of 510(k) (for both medical devices and in-vitro diagnostic devices), EU MDR, ISO
• Working knowledge of 21 CFR 820, Quality System Regulation

Skills for Regulatory Affairs Analyst Job

• 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

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