Regulatory Affairs Operations Analyst
BD is seeking a Regulatory Affairs Operations Analyst in Bengaluru to manage regulatory databases and Notification of Change processes. The role involves assessing 510(k) filing requirements, ensuring compliance for CE marked products, and coordinating documentation with R&D and QA teams. Candidates must have 2-4 years of experience in medical device regulatory affairs and familiarity with FDA standards and quality systems. This is an onsite position requiring strong project management and analytical skills.
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Experience
2-4 years
Function
Operations
Work mode
Onsite, India
Company
Tier 2
What you will work on
BD is seeking a Regulatory Affairs Operations Analyst in Bengaluru to manage regulatory databases and Notification of Change processes. The role involves assessing 510(k) filing requirements, ensuring compliance for CE marked products, and coordinating documentation with R&D and QA teams. Candidates must have 2-4 years of experience in medical device regulatory affairs and familiarity with FDA standards and quality systems. This is an onsite position requiring strong project management and analytical skills.
TAL's take
Stable role at a large, established global medical technology company with clear domain-specific requirements.
Very clear, well-defined responsibilities and expectations for a Regulatory Affairs role within a specific industry.
Must haves
- 2-4 years Regulatory Affairs experience in medical device companies
- Working knowledge of 510(k)
- Working knowledge of 21 CFR 820
- Proficient in Microsoft Word, Excel and PowerPoint
- Strong project management skills
- B.S. degree or higher in a technical discipline
Tools and skills
About the company
Established global MedTech company with significant presence, though not a top-tier software-native firm.
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