Med Device Regulator

1 week ago

pune, India beBeeSoftware Full time

Regulatory Expert for Medical DevicesWe are seeking an experienced Regulatory Expert with a strong background in FDA Quality System Regulations, including 21 CFR 11 and 21 CFR 820.A deep understanding of the regulatory landscape is crucial for this role. You will be responsible for drafting and submitting regulatory filings, such as Q-Submission requests and Traditional and Special 510(k) filings.Experience with Class I and II medical devices is essential, while additional experience with Class III devices and international device classification is a plus.Mandatory Skills:Regulatory SubmissionsMedical Device ClassificationQuality AssuranceCompliance ManagementSupply Chain ManagementAs a key member of our team, you will have the opportunity to work on a variety of projects and develop your expertise in medical device regulations. We offer a dynamic and supportive environment that encourages professional growth and development.Join us and take advantage of our expert knowledge and resources to drive your career forward.

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