Hybrid Regulatory Affairs Job at BD – Apply Online
Regulatory Affairs Operations Analyst
Hybrid, Bengaluru, Karnataka
Job ID: R-509451
Date posted: February 9, 2025
Job Type: Full-Time
Job Level: Entry to Senior
Travel: Varies
Salary: Competitive
Responsibilities
Job Description Summary
Job Description
Essential Responsibilities:
- Identify, submit, and maintain regulatory information in internal and external regulatory databases such as PIM, EUDAMED, GUDID, and FURLs.
- Provide regulatory assessment for Change Controls and provide proof of task completion in the PEGA system.
- 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, and 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.
- 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.
Qualifications:
Educational Background:
- B.S. degree or higher in a technical discipline, preferably in bioengineering, biology, chemistry, computer science, or engineering.
Professional Experience:
- 3-4 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 US regulations for medical devices and/or in vitro devices, 21 CFR 820 – Quality System Regulation, relevant standards, and FDA guidance.
- Working knowledge of EU IVDR/MDR regulations.
Skills:
- Proficient in using Microsoft Word, Excel, and PowerPoint.
- Proficient in English.
- Strong communication skills, both oral and written.
- Strong project management skills.
- Must be able to handle multiple tasks with attention to detail.
- Self-motivated and comfortable working with people remotely.
- Organized, analytical thinker with attention to detail.
Primary Work Location: IND Bengaluru – Technology Campus
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