Regulatory Affairs Analyst Hybrid Role Hiring at BD | Apply Now!
- Regulatory Affairs Analyst Hybrid Role Hiring at BD
- Join BD and Advance the World of Health™
- Job Overview
- Key Responsibilities
- Required Qualifications & Skills
- Education
- Experience
- Technical Knowledge
- Soft Skills
- Application Process
- Job Summary Table for SEO Optimization
Regulatory Affairs Analyst Hybrid Role Hiring at BD
Join BD and Advance the World of Health™
BD, a leading global medical technology company, seeks a regulatory affairs analyst to join its dynamic team in Bengaluru, Karnataka. This hybrid role offers an exciting opportunity to contribute to regulatory compliance and product submissions in the medical device industry. We encourage you to apply if you have a keen eye for detail, strong problem-solving skills, and expertise in FDA and ISO/MDD regulations.
Job Overview
- Job Title: Regulatory Affairs Analyst
- Location: Bengaluru, Karnataka (Hybrid)
- Job Type: Full-Time
- Experience Level: 3 – 8 years
- Industry: Medical Devices, Regulatory Affairs
- Salary: Competitive
Key Responsibilities
- Prepare and maintain regulatory documents for medical and in-vitro diagnostic devices.
- Assess the necessity for 510(k) submissions and prepare internal “Non-Filing Justifications” for changes.
- Develop technical files for CE marking of medical devices and ensure compliance with EU MDR regulations.
- Review and approve product labelling to meet regulatory standards.
- Collaborate with R&D, Quality, Manufacturing, and Medical teams to coordinate regulatory submissions.
- Maintain regulatory databases and provide necessary product information for registrations.
- Update standard operating procedures (SOPs), work instructions (WIs), and company policies.
- Ensure compliance with FDA, ISO 13485, and 21 CFR 820 Quality System Regulations.
Required Qualifications & Skills
Education
- Bachelor’s or Master’s in Engineering, Bioengineering, Biology, Chemistry, or related fields.
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.
Application Process
If you meet the qualifications and are ready to take on this exciting role, apply now!
🔗 Apply Here: BD Careers – Regulatory Affairs Analyst
Job Summary Table for SEO Optimization
| Company Name | Current Vacancies | Required Education | Experience Required | Location |
|---|---|---|---|---|
| BD | Regulatory Affairs Analyst | B.S./M.S. in Engineering, Bioengineering, Biology, Chemistry | 3 – 8 years | Bengaluru, Karnataka |
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