Kevin Lam Email & Phone Number
Director of Regulatory Affairs
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Kevin Lam Location
- Maple Grove, MN, US
Kevin Lam Work
- 2023 -now Director of Regulatory Affairs @ BD (formerly Edwards Lifesciences Critical Care)
- 2019 -2023 Senior Regulatory Affairs Manager @
- 2017 -2019 Senior Regulatory Affairs Manager @
- 2016 -2017 Principal Regulatory Affairs Specialist @
- 2015 -2016 Director of Regulatory Affairs @
Kevin Lam Education
- Cardinal Stritch University
Master of Business Administration (M.B.A.) (Business/Commerce, General)
2002-2004 - Bethel University
Bachelor's Degree (Registered Nursing/Registered Nurse)
1996-1999
Kevin Lam Skills
- PMA
- ISO 13485
- FDA
- Design Control
- ISO 14971
- CE marking
- Medical Devices
- CAPA
- Regulatory Affairs
- Regulatory Submissions
- Medical Device Directive
- Quality System
- 21 CFR
- V&V
- Validation
- Regulatory Requirements
- Biomedical Engineering
- Catheters
- GMP
- 21 CFR Part 11
- Sterilization
- IDE
- Clinical Trials
- Quality Auditing
- Complaint Management
- Sop
- GCP
- CTMS
- U.S. Food and Drug Administration (FDA)
- Corrective and Preventive Action (CAPA)
- Corrective and Preventive Action Capa
- Strategic Planning
- Public Relations
- u.s. Food and Drug Administration Fda
- u.s. Food and Drug Administration
- Corrective and Preventive Action
Kevin Lam Summary
- Kevin Lam, based in Maple Grove, MN, US, is currently a Director of Regulatory Affairs at BD (formerly Edwards Lifesciences Critical Care). Kevin Lam brings experience from previous roles at Boston Scientific, Stryker, Smiths Medical and Grason-Stadler. Kevin Lam holds a 2002 - 2004 Master of Business Administration (M.B.A.) in Business/Commerce, General @ Cardinal Stritch University. With a robust skill set that includes PMA, ISO 13485, FDA, Design Control, ISO 14971 and more. Kevin Lam has 5 emails and 2 mobile phone numbers on RocketReach.
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