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Regulatory Affairs Analyst Hybrid Role Hiring at BD

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BD, a global leader in medical technology, is currently hiring for the position of Regulatory Affairs Analyst in Bengaluru, Karnataka. This hybrid role offers a unique opportunity to work in a dynamic environment, contributing to regulatory compliance and product submissions in the medical device industry. If you have a passion for regulatory affairs, a keen eye for detail, and expertise in FDA and ISO/MDD regulations, this could be the perfect role for you. Read on to learn more about the job responsibilities, qualifications, and how to apply.

Regulatory Affairs Analyst Hybrid Role Hiring at BD

Job Overview

  • Job Title: Regulatory Affairs Analyst
  • Location: Bengaluru, Karnataka (Hybrid)
  • Experience Level: 3 – 8 years
  • Industry: Medical Devices, Regulatory Affairs
  • Salary: Competitive

Key Responsibilities

As a Regulatory Affairs Analyst at BD, you will play a critical role in ensuring compliance with global regulatory standards. Your key responsibilities will include:

  1. Regulatory Documentation: Prepare and maintain regulatory documents for medical and in-vitro diagnostic devices.
  2. 510(k) Submissions: Assess the necessity for 510(k) submissions and prepare internal “Non-Filing Justifications” for changes.
  3. CE Marking: Develop technical files for CE marking of medical devices and ensure compliance with EU MDR regulations.
  4. Product Labelling: Review and approve product labelling to meet regulatory standards.
  5. Cross-Functional Collaboration: Collaborate with R&D, Quality, Manufacturing, and Medical teams to coordinate regulatory submissions.
  6. Regulatory Databases: Maintain regulatory databases and provide necessary product information for registrations.
  7. SOPs and Policies: Update standard operating procedures (SOPs), work instructions (WIs), and company policies.
  8. Compliance: Ensure compliance with FDA, ISO 13485, and 21 CFR 820 Quality System Regulations.

Required Qualifications & Skills

Education

  • Bachelor’s or Master’s degree in Engineering, Bioengineering, Biology, Chemistry, or related fields.
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Experience

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

Technical Knowledge

  • Strong knowledge of 510(k) submissions, EU MDR, and ISO 13485 compliance.
  • Understanding of 21 CFR 820 Quality System Regulations.
  • Proficiency in Microsoft Word, Excel, and PowerPoint.

Soft Skills

  • Excellent communication skills (oral and written).
  • Strong analytical and problem-solving skills.
  • Ability to handle multiple tasks with attention to detail.
  • Self-motivated and comfortable working in a hybrid environment.