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Malt Strategy
Malt Strategy
Armin SAS

Armin S

Quality Assurance and Regulatory Affairs

EUR 750/Tag
Stockholm, SE
3-7 Jahre
Medical Device
ISO 13485
IEC 62304
Software as a Medical Device
Risk Management

Durchschnittliche Reaktionszeit: 1h

Über Armin

I am a Quality & Regulatory Affairs professional with 10 years of experience in the medical device industry, including 3 years focused on regulatory affairs.

I have hands-on experience working with international standards such as IEC 62304 for medical device software lifecycle processes and IEC 62366 for usability engineering and human factors. My experience includes supporting the development of Software as a Medical Device (SaMD) and ensuring that software development processes align with regulatory expectations.

I am also familiar with software validation for software used in production and quality systems, ensuring that computerized systems comply with regulatory and quality requirements.

In addition, I have extensive experience with risk management and risk assessments, both at the product level and at the business or process level, supporting organizations in identifying and mitigating regulatory and operational risks.

I also have strong general knowledge of ISO 13485 quality management systems, with practical experience in areas such as CAPA management, document control, and quality system processes.
Medizintechnik
Beratungs- und Prüfungsdienstleistungen

  • Englisch

    Muttersprachlich oder zweisprachig

  • Schwedisch

    Muttersprachlich oder zweisprachig

Nur remote
Führt Projekte hauptsächlich remote aus

Projekt- und Berufserfahrung

  • Huma
    Quality Assurance and Regulatory Affairs Specialist
    Juli 2022 - Juni 2025 (2 Jahre und 11 Monate)
    London, Vereinigtes Königreich
    • Supported the implementation and maintenance of the Quality Management System (QMS), ensuring alignment with applicable international standards and regulatory requirements.

    • Managed the document lifecycle, including preparation of templates, document review and revision, routing for approval, and maintaining proper document control within the QMS.

    • Ensured the integrity and traceability of QA documentation, enabling efficient retrieval and maintaining compliance with documentation requirements.

    • Assisted with internal and external audits and regulatory inspections, supporting preparation, documentation review, and follow-up actions.

    • Managed post-market surveillance activities, including non-conformities (NC), CAPA, complaints, adverse event reporting, and Field Safety Corrective Actions (FSCA), ensuring timely investigation and closure.

    • Maintained product registration records and regulatory documentation, ensuring accurate filing and traceability.

    • Supported regulatory submissions and product registrations, ensuring regulatory clearances were obtained in line with business timelines and addressing potential submission deficiencies when required.
    Software as a Medical Device IEC 62304 Risk Management ISO 13485 IEC 62366
  • Södersjukhuset AB
    Manager of MT-Radiography Group, Medical Technology Department
    November 2018 - Juni 2021 (2 Jahre und 7 Monate)
    Stockholm, Sweden
    Responsibilities included among others:
    - Personnel management and work environment
    - Team leadership and development
    - Dialog with clients and development of provided services
    - Quality assurance and a leading role in the Quality Management System
    - Chairman of Committee for Electrical Regulations
    - Some of the tasks of the Service engineer
  • Södersjukhuset AB
    Biomedical Engineer
    April 2016 - November 2018 (2 Jahre und 7 Monate)
    Stockholm, Sweden
    Task assignment includes among others:
    - First-line support for most radiographic system
    - Second-line support for radiographic systems where cooperation service agreement is present
    - Technical first-line support for medical image storage systems, among other Sectras RIS/PACS
    - Technical consultation during purchasing, planning, and installation of new radiographic equipment
    - Providing the hospital with expertise for projects when radiographic equipment is effected
    - Member of Committee for Electrical Regulations that support Södersjukhuset AB in fulfilling electrical redundancy requerments according to Swedish regulations.
Gesamte Berufserfahrung von Armin ansehen

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Ausbildung und Abschlüsse

  • Medical Device Regulation (MDR)
    Medical Device Regulation (MDR)
  • Master of Business Administration - MBA
    Waseda University
    2022
    Master of Business Administration - MBA
Ausbildung und Abschlüsse von Armin ansehen

Fähigkeiten

IEC 62366
ISO 14971

Kategorien

  • Sonstige