Regulatory Affairs Specialist Job at BD |Apply Now!
Looking for a dynamic career in regulatory affairs? This Regulatory Affairs Specialist role in the medical device industry offers a challenging yet rewarding opportunity to work with regulatory compliance, international product registrations, and new product development.
If you have a strong technical background and expertise in 510(k) submissions, CE marking, and FDA regulations, this could be the perfect job for you. Read on to learn more about the key responsibilities, qualifications, and skills required for this role.
About the Job
As a Regulatory Affairs Specialist, you will be key in managing and ensuring regulatory compliance for medical devices. This position involves regulatory data collection, entry, and assessment while supporting all business compliance objectives. Strong analytical, problem-solving, and technical evaluation skills are essential for success in this role.
Key Responsibilities
- Identify, submit, and maintain regulatory data in compliance databases.
- Assess and determine the need for 510(k) applications for device modifications.
- Prepare Non-Filing Justifications (U.S.) for device changes not requiring a 510(k) submission.
- Develop technical files for CE marking, collaborating with R&D, Quality, and Manufacturing teams.
- Evaluate significant changes to CE-marked products and ensure timely notifications to Notified Bodies.
- Review and approve product labeling for regulatory compliance.
- Maintain updated regulatory documentation in collaboration with cross-functional teams.
- Submit regulatory information to external databases when necessary.
- Develop and update Standard Operating Procedures (SOPs) and work instructions.
- Coordinate responses to product data and information requests.
Qualifications & Experience
- Education: B.S. in computer science, engineering, bioengineering, biology, or chemistry.
- Experience: 2-4 years in Regulatory Affairs within the medical device industry, focusing on international registrations, product development, and compliance.
Knowledge & Skills
- Expertise in 510(k) submissions, MDD 93/42/EEC, and 21 CFR 820 Quality System Regulation.
- Familiarity with material-related regulations (Prop 65, DOT, IATA, OSHA, etc.) across the U.S., Europe, and Canada.
- Strong proficiency in Microsoft Word, Excel, and PowerPoint.
- Excellent communication and project management skills.
- Detail-oriented, self-motivated, and capable of managing multiple tasks.
Location & Work Shift for Regulatory Affairs Specialist Job Role
- Primary Work Location: IND Bengaluru – Technology Campus
- Work Shift: Based on company requirements
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