Regulatory Affairs Analyst Role | BD Job Opening | Bengaluru, India
Are you an experienced Regulatory Affairs professional with a passion for medical devices and in vitro diagnostics? BD (Becton, Dickinson, and Company) is looking for a Regulatory Affairs Analyst in Bengaluru, Karnataka! Join a global leader in medical technology and play a crucial role in ensuring regulatory compliance for cutting-edge healthcare solutions.
About BD (Becton, Dickinson, and Company)
BD (Becton, Dickinson, and Company) is a leading global medical technology company dedicated to advancing healthcare by improving medical discovery, diagnostics, and the delivery of care. With a legacy spanning over 125 years, BD develops innovative solutions that enhance research, clinical diagnostics, and patient care across the world.
Regulatory Affairs Analyst Role Details
- Job Title: Regulatory Affairs Analyst
- Location: Hybrid, Bengaluru, Karnataka
- Job ID: R-510424
- Job Type: Full-Time
- Job Level: Entry to Senior
- Travel: Varies
- Salary: Competitive
Regulatory Affairs Analyst Role Description Summary:
This position is responsible for the creation, identification, collection, and entry of regulatory affairs information on medical devices and in vitro diagnostic devices. Support related regulatory affairs activities, such as assessment, execution, and management of procedures and systems designed to ensure that the product development process addresses all regulatory
needs and objectives of the business. Requires the analysis of data, problem-solving analysis, and in-depth evaluations of various factors.Essential Responsibilities for Regulatory Affairs Analyst Role
- Identify, submit, and maintain regulatory information in databases
- Support assessment for necessary submissions and prepare justifications
- Prepare technical files for CE marking of devices
- Review and approve labeling for regulatory compliance
- Coordinate and collect registration information
- Submit regulatory information to external databases
- Responsible for writing and updating SOPs, WIs, and policies
Educational Background for Regulatory Affairs Analyst Role: B.S. degree or higher in a technical discipline, preferably in computer science, engineering, bioengineering, biology, or chemistry.
Professional Experience: 3-8 years in Regulatory Affairs in medical device companies.
Knowledge:
- Working knowledge of 510(k) (for both medical devices and in-vitro diagnostic devices), EU MDR, ISO
- Working knowledge of 21 CFR 820, Quality System Regulation
Skills Required for Regulatory Affairs Analyst Role:
- 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 and pay attention to detail.
- Self-motivated, comfortable with working with people remotely
- Organized, analytical thinker with attention to details
Primary Work Location
IND Bengaluru – Technology Campus
Additional Information
- Work Shift: TBD
Keywords: Regulatory Affairs Analyst, Bengaluru, Karnataka, Medical Devices, In Vitro Diagnostic, CE Marking, Regulatory Compliance, Regulatory Affairs Analyst Role
