Summary
Work History
Education
Skills
Otherskillsandattributes
Certificationsandachievements
Additionalreferees
Professionaloverview
Languages
Timeline
Generic
Azadeh Sadeghi

Azadeh Sadeghi

East Perth,Australia

Summary

As a biomedical engineer and master's degree holder in medical information technology, with years of experience in various aspects (sales, after-sales services, medical IT, quality control and assurance , regulations, and standards in the medical device sector), both in Iran and Australia, I am interested in serving as a quality team member @ the service of healthcare related organizations or companies, continuing my professional activities.

Bringing dedication to compliance and precision, well-versed in regulatory guidelines and documentation requirements, coupled with strong analytical and problem-solving skills. Adept at interpreting and applying regulatory information, ensuring all processes align with legal standards. Committed to delivering high-quality results that enhance operational efficiency and mitigate risks.

Work History

Regulatory Affairs Specialist

Linear Medical
  • Company Overview: Ramsay Healthcare Australia
  • Ramsay Healthcare Australia

Biomedical Engineer and Regulatory Specialist

Sydney Adventist Hospital

Manager of Medical Equipment Services

Chemtronics Biomedical Engineering Co.
  • Company Overview: Central Facility
  • Central Facility

Apprentice

Flinders Hospital
  • Company Overview: Biomedical department
  • Biomedical department

Biomedical Engineer, Sales and After-Sales Service Manager

Arman Tandorost
  • Company Overview: Arya Tandorost
  • Arya Tandorost

Education

Several ongoing professional related trainings, conferences & seminar, Memberships and self-studies.

Business Management - Business Administration And Management

TAFE NSW
NSW
01.2015

Master's - Medical Information Technology

Amir Kabir University of Technology
01.2009

Bachelor's - Biomedical Engineering

Islamic Azad University
01.2002

Skills

  • Implementation and knowledge of ISO 13485 and ISO 9001 regulations
  • Experience with Australian and Iranian medical companies
  • Regulatory affairs
  • Quality Control
  • ISO certification
  • Setting up sales and after-sales service units
  • Launching medical equipment testing and calibration
  • Managing multiple projects concurrently
  • Obtaining approvals from health authorities
  • Liaising with Chinese manufacturers
  • Consulting services
  • Documentation management
  • Compliance with regulations
  • Internal audits
  • Rewriting internal procedures
  • Market analysis
  • Leading various projects
  • Develop QC implementation methods
  • Adhering to manufacturers' guidelines
  • ECRI
  • IEC series
  • AMMI/ANSI
  • IT integration
  • Proficient in computer and Office software
  • Attention to detail
  • Teamwork skills
  • Innovative thinking
  • Organizational skills
  • Time management
  • Problem-solving abilities

Otherskillsandattributes

  • Representative and responsible for IT integration in the organization, simultaneous with the establishment of after-sales service units and calibration.
  • Proficient in computer and Office software, fully fluent in English (commercial + medical)
  • Personal qualities: attention to detail, teamwork skills, innovative thinking, organizational skills, time management, and problem-solving abilities.

Certificationsandachievements

  • Official certificate of appreciation from Owan CEO
  • Ranked first among graduates of the Master's program in Health Information Technology at the Amir Kabir University of Technology.

Additionalreferees

Further referees available upon request via LinkedIn

Professionaloverview

As a biomedical engineer and master's degree holder in medical information technology, with years of experience in various aspects (sales, after-sales services, medical IT, quality control and assurance, regulations, and standards in the medical device sector), both in Iran and Australia, I am interested in serving as a quality team member @ the service of healthcare related organizations or companies, continuing my professional activities.

Languages

English
Full Professional
Arabic
Elementary
Persian
Native or Bilingual

Timeline

Master's - Medical Information Technology

Amir Kabir University of Technology

Bachelor's - Biomedical Engineering

Islamic Azad University

Regulatory Affairs Specialist

Linear Medical

Biomedical Engineer and Regulatory Specialist

Sydney Adventist Hospital

Manager of Medical Equipment Services

Chemtronics Biomedical Engineering Co.

Apprentice

Flinders Hospital

Biomedical Engineer, Sales and After-Sales Service Manager

Arman Tandorost

Several ongoing professional related trainings, conferences & seminar, Memberships and self-studies.

Business Management - Business Administration And Management

TAFE NSW
Azadeh Sadeghi