Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
Timeline
Generic
Sahba Eslaminezhad

Sahba Eslaminezhad

Irvine

Summary

Regulatory Affairs Specialist with 3+ years of experience in preparing and managing international medical device submissions. Proven ability to collaborate with global affiliates, develop and execute regulatory strategies, and ensure compliance with diverse OUS regulatory frameworks. Skilled in reviewing labeling, coordinating with cross-functional teams, and providing strategic guidance for global product registrations and lifecycle management

Overview

8
8
years of professional experience
1
1
Certification

Work History

Regulatory Affairs (OUS Submission)

Pars Biotech Research & Development Co
Shiraz
02.2021 - 11.2024
  • Prepared and finalized regulatory submissions for OUS affiliates, ensuring protection of proprietary data and compliance with country-specific requirements.
  • Tracked project milestones and submission timelines, reporting progress and risks to senior regulatory leadership.
  • Contributed to the development of global regulatory strategies and contingency planning, focusing on accelerated approval pathways.
  • Provided input on regulatory requirements in cross-functional teams (R&D, Quality, Manufacturing), resolving conflicts between product development and compliance standards.
  • Reviewed product labeling and technical documents to ensure accuracy, consistency, and adherence to international regulatory standards.
  • Advised business units on global registration requirements, renewals, and change notifications, based on historical data and affiliate feedback

Regulatory Affairs Associate

Ohad med
Shiraz
04.2017 - 01.2021
  • Supported international regulatory submissions by preparing documentation, compiling technical files, and tracking approval status across LATAM and APAC markets.
  • Reviewed product and process changes to assess regulatory impact and supported risk-based change management.
  • Assisted in responding to inquiries from regulatory authorities, notified bodies, and global affiliates.
  • Participated in internal audits and supported CAPA actions related to regulatory compliance.

Education

M.Sc. - Chemical Engineering

Azad University of Shiraz
Shiraz, Iran
01.2019

B.Sc. - Chemical Engineering

Azad University of Shiraz
Shiraz, Iran
01.2015

MBA -

Tehran University
Tehran, Iran
01.2021

Skills

  • Regulatory Systems: eSTAR, RIMS, Veeva Vault
  • Documentation: Technical Files, STED, CERs
  • Standards: ISO 13485, MDR, MDSAP, 21 CFR Part 820

Accomplishments

  • (1) Evaluation of the wound healing efficacy of new antibacterial polymeric nanofiber based on polyethylene oxide coated with copper nanoparticles and defensin peptide: An in-vitro ... S Eslaminezhad, F Moradi, MR Hojjati Heliyon 10 (8)
  • (2) How Nanomaterials Act against Bacterial Structures? A Narrative Review by Focusing on Molecular Mechanism of the Nanoparticles M Bahrami, PS Shirazi, F Moradi, N Hadi, S Eslaminezhad Microbial Pathogenesis, 107002
  • (3) The Antibacterial and Antioxidant Effects of Polyethylene Oxide Nanofibers Containing Plant Peptide and Copper S Eslaminezhad, MR Hojjati, F Moradi Iranian South Medical Journal 26 (3), 167-177
  • (4) A Molecular of the Nanomaterials against Multidrug-resistant Bacteria M Bahrami, P Serati Shirazi, N Hadi, S Eslaminezhad, F Moradi 1st International Congress Pharmaceutical Biomaterials
  • (5) Antimicrobial Nanofibers and Textiles in Medicine “Importance, Design Technology & Applications” S Eslaminezhad, F Moradi ISBN: 978-622-08-8470-5
  • (6) Frequency and antimicrobial resistance of Shigella species in Iran during 2000-2020 F Moradi, S Eslaminezhad, R Mahrokh The 16th Alborz International Congress of Clinical Microbiology
  • (7) Designing Antibacterial Nano Composite Based on Polyethylene Oxide Polymer Coated with Copper Nanoparticles & Defensin Peptide with Wound Healing Properties S Eslaminezhad, F Moradi The 16th Alborz International Congress of Clinical Microbiology

Certification

  • Regulatory Affairs Certification (RAC) – In Progress
  • Patent Registration
  • Design Expert
  • Awarded in 16th Professor Alborzi International Congress of clinical Microbilogy

Timeline

Regulatory Affairs (OUS Submission)

Pars Biotech Research & Development Co
02.2021 - 11.2024

Regulatory Affairs Associate

Ohad med
04.2017 - 01.2021

M.Sc. - Chemical Engineering

Azad University of Shiraz

B.Sc. - Chemical Engineering

Azad University of Shiraz

MBA -

Tehran University

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Sahba Eslaminezhad