Hybrid Biology Jobs at BD – Apply For Regulatory Affairs Ops Analyst Role

Hybrid Biology Jobs India at BD – Apply For Regulatory Affairs Ops Analyst Role

Regulatory Affairs Operations Analyst

Location: Hybrid, Bengaluru, Karnataka

Job ID: R-505419

Date Posted: December 11, 2024

Responsibilities

Job Description Summary:

This position is responsible for the creation, identification, collection, and entry of regulatory affairs information of medical devices. It supports related regulatory affairs activities, such as assessment, execution, and management of regulatory data and information to meet the business’s regulatory needs and objectives. The role requires data analysis, problem-solving, and in-depth evaluations of various factors.

Job Description: P2-14313

Essential Responsibilities:

• Identify, submit, and maintain regulatory information in regulatory databases.
• Assess the necessity for submitting a 510(k) application for proposed device changes and prepare internal “Non-Filing Justifications” (U.S.) for changes that do not require a 510(k) submission.
• Prepare technical files for CE marking with input/help from various functions (R&D, Quality, Manufacturing, etc.) in a timely manner.
• Assess the necessity for notifying the Notified Body about significant changes to CE-marked products and prepare documentation updates for non-significant changes 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.
• Coordinate and collect specific registration information with R&D, Manufacturing, QA, Medical, and other applicable departments to update regulatory documentation.
• Submit regulatory information on products to external databases when necessary.
• Write and update standard operating procedures (SOP), work instructions (WI), and policies as needed.
• Coordinate and respond to requests for product data and information.

Qualifications

Educational Background: B.S. degree or higher in a technical discipline, preferably in computer science, engineering, bioengineering, biology, or chemistry.

Professional Experience: 2-4 years of 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 medical devices), MDD 93/42/EEC, and 21 CFR 820 – Quality System Regulation.
• Working knowledge of standards and FDA guidance documents.
• Familiarity with material-related regulatory requirements (e.g., Prop 65, CONEG, DOT, IATA, IMO, OSHA, etc.) in the US, Europe, and Canada.

Skills:

• Proficient in Microsoft Word, Excel, and PowerPoint.
• Proficient in English.
• Strong oral and written communication skills.
• Strong project management skills.
• Ability to handle multiple tasks with attention to detail.
• Self-motivated and comfortable working remotely.
• Organized, analytical thinker with attention to detail.

Primary Work Location: IND Bengaluru – Technology Campus

APPLY ONLINE HERE

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