обновлено 8 дней назад
IT Compliance Officer (MedTech)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
IT Compliance Officer (MedTech): Driving IT compliance, information security, and regulatory alignment for point-of-care diagnostic solutions with an accent on ISMS, IT SOX, software validation, and NIS2 compliance. Focus on improving governance frameworks, maintaining audit readiness, and implementing regulatory requirements across a regulated global environment.
Location: Ängelholm, Sweden; primarily on-site with flexibility
Company
HemoCue, part of , develops point-of-care diagnostic solutions for hemoglobin, glucose, HbA1c, and white blood cell testing.
What you will do
- Own and continuously improve the Information Security Management System.
- Drive the IT SOX program, including controls, testing, and remediation.
- Lead NIS2 compliance activities and serve as a regulatory contact.
- Maintain and improve GxP and computer system validation processes.
- Monitor and implement regulatory developments, including NIS2 and ISO 27001.
Requirements
- Bachelor’s degree in Engineering, Computer Science, or a related field, or equivalent experience.
- Some years of experience in IT compliance, IT audit, or information security.
- Knowledge of NIS2, SOX, GxP/CSV, and risk management.
- Familiarity with ISO 27001, ISO 13485, and GDPR.
- Experience working in regulated or global environments.
Nice to have
- Experience in MedTech or another regulated industry.
- Experience in global matrix organizations.
- Experience with continuous improvement frameworks.
Culture & Benefits
- Work within the Procurement & IT function and report to the Director of Procurement & IT.
- Collaborate across functions in a fast-paced, global environment.
- Contribute to building a world-class compliance and governance organization.
- Work in a culture focused on belonging, continuous improvement, and advancing healthcare outcomes.
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