Alay Bhayani
Director, Regulatory Affairs Strategy @AbbVie
Newport Beach, CA, US
EMAILS
a••••••••@abbvie.com
MOBILE NUMBERS
+13•••••••94
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WORK HISTORY
Mar 2022 — Present
Director, Regulatory Affairs Strategy @AbbVie
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Summary: Utilizing in-depth understanding of regulations, develop and implement global regulatory strategy on enterprise critical assets. Plan and prepare complex regulatory submissions for global regulatory filings. Support management with regulatory programs planning, implementation of departmental policies, and employee engagement and development. Perform due diligence for business development opportunities.
SKILLS
Medical DevicesIso 14971Ce MarkingCapaV&VIso 13485PmaRegulatory AffairsRegulatory Submissions510(K) SubmissionBiomedical EngineeringValidationQuality SystemPma Submission21 CfrFdaDesign Control
ABOUT ALAY BHAYANI
Author of “Medical Device Submissions” chapter in the book “Fundamentals of US…
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