Are you ready to take your career in Regulatory Affairs to the next level? BD, a global leader in medical technology, is seeking a Regulatory Affairs Operations Analyst in Bengaluru, Karnataka. This hybrid role offers you the opportunity to play a pivotal role in maintaining high regulatory standards for medical devices and contribute significantly to advancing the world of health. If you have a passion for regulatory compliance, possess excellent analytical skills, and are eager to stay updated with the latest industry regulations, this might be the perfect opportunity for you!
Key Responsibilities
As a Regulatory Affairs Operations Analyst, your primary responsibilities will include:
- Regulatory Database Management: Identify, submit, and maintain regulatory information in internal databases such as RIM, DMS, and PIM.
- Change Control Assessments: Provide regulatory assessments for Change Controls, ensuring completion of tasks and notifications in the PEGA system.
- Notified Body Notifications: Assess the necessity for notifications to the Notified Body for significant changes to CE marked products and prepare timely documentation updates for non-significant changes.
- Documentation Review: Complete, review, and approve documentation to ensure compliance with regulatory standards.
- Cross-Department Coordination: Collaborate with R&D, Manufacturing, QA, and Medical departments to coordinate and collect necessary registration information for regulatory documentation updates.
- Regulatory Information Submission: Submit product regulatory information to internal and external databases as required.
- Standard Operating Procedures: Write and update Standard Operating Procedures (SOP), Work Instructions (WI), and policies as needed.
- Data Requests: Coordinate and respond to requests for product data and information from regulatory bodies and internal stakeholders.
Qualifications
Educational Background
- Degree: A B.S. degree or higher in a technical discipline is required, preferably in bioengineering, biology, chemistry, computer science, or engineering.
Professional Experience
- Candidates should have 3-4 years of experience in Regulatory Affairs within medical device companies, encompassing international product registrations and new product development.
Knowledge and Skills
- Regulatory Knowledge: A solid understanding of US regulations for medical devices (including 21 CFR 820 – Quality System Regulation) and EU IVDR/MDR regulations is essential.
- Technical Skills: Proficiency in Microsoft Word, Excel, and PowerPoint, along with excellent command of the English language.
- Communication Skills: Strong oral and written communication skills are necessary to effectively collaborate with cross-functional teams.
- Project Management: Strong project management abRegulatory Affairs Operations Analystilities to handle multiple tasks efficiently while maintaining high attention to detail.
- Self-Motivated: Ability to work remotely and independently, demonstrating strong organizational and analytical thinking skills.
Why Join BD?
At BD, we believe in fostering an environment that supports continuous learning and professional growth. Working here means you will have access to regular learning opportunities, enabling you to stay abreast of evolving regulations in the medical device sector. Join a team that values innovation, diversity, and collaboration, as we work together toward narrowing the health gaps across the globe.
