Mridi Wehls
Associate Director at Shockwave Medical (J&J Medtech)
- Role
- Associate Director at Shockwave Medical
- Location
- San Francisco, CA, US
- LinkedIn followers
- 500 followers
About Mridi Wehls
RAC certified regulatory professional. Highly proficient in global regulatory strategy development, 510(k)s, PMAs, MDR & IVDR Technical Files, advertising and promotion. Experienced in a wide variety of medical devices including implants, single use, capital equipment and software, in vitro diagnostics.
Experience
Associate Director
Sep 2023 — Present · Santa Clara, CA, US
Education
The Johns Hopkins University
Master of Science (MS), Biotechnology (Concentration: Regulatory Affairs)
The University of Utah
Bachelor of Science (B.S.), Biomedical Engineering
Skills
- Product Validation
- Fda
- Lean Manufacturing
- Ce Marking
- Product Development
- Root Cause Analysis
- Quality System
- V&V
- Iso 13485
- Organizational Leadership
- Quality Engineering
- Cqe
- Quality System Regulations
- Quality Auditing
- Biomedical Engineering
- Quality Assurance
- Design for Manufacturing
- Quality Control
- Gmp
- Design Control
- Technical Writing
- Strategic Planning
- Regulatory Submissions
- Validation
- Biomaterials
- Supplier Quality
- Iso 14971
- Certified Quality Engineer (Asq)
- Asq Certified Quality Auditor
- Process Validation
- Fmea
- Qsr
- Project Planning
- Spc
- Medical Device Product Development
- Cqa
- U.s. Food and Drug Administration (Fda)
- Design of Experiments
- Canadian Medical Device Regulations
- Medical Devices
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.