Swati Rawat
Director, Regulatory Toxicology and Biocompatibility at BD, Ex-Edwards
- Role
- Director, Quality (Global Biocompatibility and Toxicology) at BD
- Location
- Irvine, CA, US
- LinkedIn followers
- 500 followers
About Swati Rawat
Dynamic and results-oriented medical device leader with proven experience overseeing a $1B revenue global product portfolio and driving strategy, innovation, and compliance across critical care, heart valves, and advanced delivery systems. Dedicated to solving complex challenges that advance patient care, with deep expertise in regulatory, quality, and biocompatibility requirements across U.S. and international markets.Recognized for extensive leadership experience, guiding high-performing teams and multiple simultaneous projects to successful, timely outcomes. Highly skilled in shaping regulatory strategy, establishing biocompatibility/safety testing frameworks, and driving compliance with FDA, ISO, and global health authority requirements (EU MDR, MDD, NMPA, PMDA, MFDS).Actively engaged with AAMI Standards Committees and FDA Working Groups, leveraging strong networks within the regulatory and quality community to influence industry practices and standards. Adept at technical writing, submissions (510(k), PMA), audits, and cross-functional collaboration with R&D, manufacturing, and clinical teams.With certifications as a Lead Auditor, advanced training in cGMP/GLP/GCP, and hands-on experience spanning assay development, clinical compliance, and global submissions, I bring a unique blend of scientific knowledge, regulatory expertise, and executive leadership.Specialties: Regulatory strategy | Global product portfolio management | FDA & ISO13485 compliance | ISO 10993 biocompatibility | Quality Systems leadership | Clinical compliance (GCP/GLP)| Risk management | Assay and protocol development | Technical reporting | Cross-functional team leadership
Experience
Director, Quality (Global Biocompatibility and Toxicology)
Mar 2025 — Present
Leading Biocompatibility and Toxicology team at BD APM.
Education
UC Irvine School of Medicine
Post Doctoral Fellowship, Physiology and Biophysics
2011 — 2015
Holkar Science Collge
B.S, Biotechnology
2002 — 2004
Devi Ahilya Vishwavidyalaya
M.S, Biotechnology
2004 — 2006
Wayne State University
Biochemistry and Molecular Biology
2006 — 2011
Skills
- Biotechnology
- Protein Purification
- Cell
- Cell Culture
- Protein Chemistry
- Elisa
- Life Sciences
- Western Blotting
- Lifesciences
- Purification
- Biochemistry
- Dna
- Assay Development
- Immunofluorescence
- Molecular Biology
- Tissue Culture
- Transfection
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