Benjamin Kimball
Vice President of Quality and Regulatory Affairs, Compliance Officer at Tides Medical
- Role
- Vice President of Quality and Regulatory Affairs, Compliance Officer at Tides Medical
- Location
- Lafayette, LA, US
- LinkedIn followers
- 500 followers
About Benjamin Kimball
I am a regulatory and quality professional with nearly 30-years of experience in the medical device industry, including bioinformatics, analytics software (SaMD), in vitro diagnostics, and implants. I have a strong multi-functional background where my primary responsibilities have focused on management and oversight of all quality, and regulatory topics. My projects have ranged from the development of Quality Management Systems (QMS), QMS uplifts and rebuilds, e.g. IVDR implementation, compliance programs (FCPA, AKS, FCA, etc.), to dozens of product clearances. I have a unique approach to Regulatory and Quality management derived from my legal background and many years in the RA/QA field, with a focus on applying my deep regulatory knowledge to the development and execution of strategies for achieving corporate compliance goals.Specialties: QMS development and management, Medical Device law & regulation, IVDR, Class I, II, Medical Devices, IVD, 510(k), MDR, IVDD, 21 CFR 820, False Claims Act, HIPPA compliance, Implants, CE marking, international device registration, ISO 13485, regulatory compliance, governmental affairs, global quality system management, audits, FCPA compliance, Anti-Kickback, OIG Guidance, Sunshine Act.
Experience
Vice President of Quality and Regulatory Affairs, Compliance Officer
May 2021 — Present · Lafayette, LA, US
Responsible for oversight of all compliance, regulatory and quality activities.
Education
Notre Dame College
Dual majored in Biotechnology and Microbiology, B.A. Microbiology / Biotechnology
1995 — 1998
Thomas Jefferson School of Law
Juris Doctor, Law
2002 — 2005
Skills
- Regulatory Affairs
- Iso 13485
- Medical Devices
- Quality System
- Fda
- Design Control
- Quality Assurance
- Gmp
- Capa
- Regulatory Submissions
- Ce Marking
- Validation
- Quality Management
- Ivd
- Oncology
- Regulatory Requirements
- Quality Auditing
- Change Control
- 21 Cfr Part 11
- Management Review
- Auditing
- Food & Drug Law
- Clia
- Life Sciences
- U.s. Food and Drug Administration (Fda)
- Standard Operating Procedure (Sop)
- U.s. Title 21 Cfr Part 11 Regulation
- Corrective and Preventive Action (Capa)
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