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Digital Compliance Lead @

3 weeks ago

Remote Warszawa, Czech Republic SquareOne Full time

Required Qualifications:

  • Demonstrated experience in managing change in complex, global environments.
  • Ability to build strong relationships and navigate through ambiguity.
  • Experience with regulatory requirements and risk management within the healthcare or medical device sectors.
  • Strong problem-solving skills with a focus on delivering business impact in a large global organization.
    • 5+ years of experience in quality assurance for software development in large, global IT environments, ideally in the medical device industry.
    • Practical knowledge of 21 CFR Part 11, 21 CFR Part 820, EMA Annex 11, EMA MDR, IVDR, and ISO 13485.
    • Experience in quality assurance for Software as a Medical Device (SaMD) development.
    • Strong understanding of risk management principles and software development life cycle methodologies, including Agile.
    • Knowledge of privacy regulations (e.g., GDPR, HIPAA) and their application to service providers.
    • Experience in audits, IT security, and privacy management is desirable.

Position Overview: We are seeking a highly skilled Digital Compliance Lead to join our dynamic Informatics community. This is an exciting opportunity to work with a diverse team of professionals who are passionate about advancing healthcare solutions. The role focuses on ensuring that our partner's digital environment and products comply with regulations, are secure, and manage risks effectively. You will play a key role in evaluating third-party services, supporting digital compliance processes, and leading risk management efforts across global teams.

This role offers the chance to make a real impact on global healthcare challenges by ensuring digital compliance across a wide array of services and products. If you are driven by solving complex problems and have a passion for healthcare and compliance, we encourage you to apply

Terms & Conditions:

  • B2B contract
  • Fully remote
  • Work on your own devices
  • 2 interview
,[Perform qualification activities related to the digital compliance of service providers, including Contract Research Organizations (CROs), digital healthcare solutions, medical devices, and software as medical devices (SaMD). , Provide expertise on computerized systems to support business partners in selecting and managing service providers. , Support clinical study teams with digital compliance-related issues for service providers. , Review and assess service providers' digital risks, including mitigation plans and evidence to ensure high-risk areas are properly addressed. , Conduct vendor risk assessments to evaluate whether third parties have the necessary compliance controls to minimize risks the company and its customers. , Work closely with internal teams and external technology providers to understand and mitigate digital compliance risks. , Act as a trusted partner for business, procurement, and quality teams, maintaining strong relationships across the organization. , Stay up-to-date with global regulatory frameworks such as 21 CFR Part 11, 820, EMA MDR, IVDR, EU GDPR, HIPAA, CCPA, PIPL, and others. ] Requirements: risk management, Quality assurance, ISO, Software Development Life Cycle, Audits, Security