Hemal Mehta

About Hemal Mehta

Candidate possesses an M.S. in Biomedical Engineering with significant in-depth academic research, start-up, and corporate industry experience. Seeking a position which synthesizes my academic background with my business experience to translate clinical innovations into real world applications.

Experience

1. Associate Director, Global Cmc Regulatory Affairs, Medical Devices and Combination Products

   Johnson & Johnson Innovative Medicine

   Aug 2017 — Present · Malvern, PA, US

   Supported global pre- and post-approval regulatory activities related to the Company’s combination products, borderline products (i.e. drug-delivery devices) and standalone medical devices intended for drug delivery for large and small molecule drugs, vaccines, and gene therapies, inclusive of developing product-specific regulatory strategy documents, authoring Health Authority briefing package content, providing technical review and approval of device design verification and validation protocols and reports, and assessing change controls.• Authored combination product IND, CTA, BLA, MAA, iCTD submissions, in addition to device-specific clinical submissions, and direct interaction experience with global Health Authorities.• Provided direction to both Drug and Device Development Teams on the interpretation and application of global CMC and delivery device regulations and guidances related to combination products (e.g. 21 CFR Part 4, cGMPs for combination products, 21 CFR Part 820 Design Controls, EU Medicinal Products Directive, EU Medical Device Directive, and EU Medical Device Regulation Article 117).• Shaped regulatory policy development via industry groups and directly with regulatory agencies.• Advanced organizational diversity, equity, and inclusion (DE & I) culture by active participation and leadership in J&J South Asian Professional Network Association (SAPNA) employee resource group (ERG) and Janssen Global Regulatory Affairs DE & I Champions Forum and Communications sub-team.

Education

• Boston University

  M.S., Biomedical Engineering

  2001 — 2004

• University of Tennessee, Knoxville

  B.S., Engineering Science (Biomedical Engineering concentration)

  1996 — 2000

Skills

• Gmp
• Quality System
• V&V
• Regulatory Affairs
• Lifesciences
• Orthopedic
• Commercialization
• Pharmaceutical Industry
• Orthopedics
• Fda
• Spine
• Technology Transfer
• Biomechanics
• Iso 13485
• R&D
• Hardware Diagnostics
• Biotechnology
• Medical Imaging
• Design Control
• Statistics
• Minitab
• Laboratory
• Data Analysis
• Product Launch
• Clinical Trials
• Medical Devices
• Clinical Research
• Capa
• Tissue Engineering
• 21 Cfr Part 11
• Regulatory Submissions
• Cross-Functional Team Leadership
• Biomaterials
• Iso 14971
• Biomedical Engineering
• Design of Experiments
• Validation
• Research