プロフィール詳細

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Saleha A.に依頼

Pakistan

Medical Device Regulatory Affairs Specialist | FDA 510(k) | EU MDR/IVDR | CER, BER & Technical Documentation Consultant

プロフィール概要

I am a Medical Device Regulatory Affairs Specialist and Technical Documentation Consultant with experience supporting manufacturers and healthcare companies in regulatory compliance, technical writing, quality systems, and international market approvals. I work with global clients across the USA, UK, Europe, Middle East, and Asia on projects related to FDA, EU MDR xxxxxxxx, IVDR xxxxxxxx, ISO 13485, ISO 14971, ISO 10993, TGA, MHRA, and other international regulatory frameworks. My expertise includes: • FDA 510(k), MDR, IVDR, UKCA, and TGA regulatory documentation • Clinical Evaluation Reports (CER) • Biological Evaluation Reports (BER) • Risk Management Files (ISO 14971) • Technical Documentation and Technical Files • Post-Market Surveillance (PMS) documentation • Usability Engineering documentation (IEC 62366) • Labeling and IFU review • Literature Search and Regulatory Research • Quality Management System (QMS) documentation • Regulatory gap assessments and compliance strategy I have supported projects involving: • Balloon Catheters • Intracranial Stents • Dental Instruments • Wearable Medical Devices • Blood Collection Kits • Wound Care Devices • Extraction Systems • Diagnostic Devices (IVDR) I am associated with Kounter Intuitive Technologies (KIT), an international regulatory consulting company with experience supporting medical device manufacturers and healthcare organizations globally. In addition to Regulatory Affairs, I also have experience in: • Technical & Scientific Writing • Academic and Research Writing • Regulatory Research For EU MDR: "I specialize in MDR xxxxxxxx remediation, specifically converting MDD Technical Files to MDR GSPR compliance and authoring Clinical Evaluation Reports (CER) that satisfy Notified Body requirements." For US FDA: "I have experience with the mandatory eSTAR template for 510(k) submissions and can assist in drafting Cybersecurity risk assessments and Human Factors reports per the latest 2024/2025 FDA guidances." I focus on delivering accurate, well-structured, compliance-focused, and submission-ready documentation tailored to client and regulatory requirements.

専門分野

• ☆ Drug Development
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Medical Devices
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ Clinical Trials
• ☆ Regulatory Affairs
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing
• ☆ Medical Device Literature Reviews
• ☆ Clinical Evaluation Reports (CER)
• ☆ Premarket Notification/510(k) Submission
• ☆ Investigational Device Exemption (IDE)
• ☆ PreMarket Approval (PMA) Applications
• ☆ CMC Documentation
• ☆ NDA/BLA Applications
• ☆ Nonclinical Study Documentation
• ☆ Investigational New Drug (IND) Application Writing

サービス

• Writing
• Research
• Consulting
• Data & AI

Writing Clinical Trial Documentation, Technical Writing

Research Market Research, User Research, Fact Checking, Gap Analysis, Gray Literature Search, Systematic Literature Review

Consulting Digital Strategy Consulting

Data & AI Statistical Analysis, Data Processing

職務経験

manager

kounter intuitive technologies

6月 2017 - 現在

Managing Director (Technical)

Kounter Intuitive technology

1月 2015 - 現在

学歴

bachelors

punjab college lahore

8月 2009 - 9月 2011

Bachelors in General Sciences

university of Lahore

2月 2009 - 9月 2011

認定資格

• MDCG Guidance Documents

  REVIVE MEDICAL TECHNOLOGIES

  8月 2025 - 現在

• ISO 14971 Medical Device Risk Management, ISO/TR 24971 Risk Management Guidance

  SGS

  3月 2023 - 現在

• MDR Technical Documentation Transition Training Course

  SGS

  6月 2021 - 現在

• ISO 9001:2015 Quality Management System Auditor/Lead Auditor Training Course

  SGS

  11月 2020 - 現在

• Certificate on Completation of ISO 13485:2016 Medical device quality management system transition course

  Medical Device Development Center (MDDC) National University Of Scinces & Technologies (NUST)

  7月 2016 - 現在

• ISO 13485:2016 Medical Devices Quality Management System Intriduction Training Course

  SGS

  1月 2021 - 1月 2021

• Medical Device Regulation (EU)2017/745 Implementation Course

  SGS

  7月 2019 - 1月 2021