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