Product Compliance Specialist

Scalo is offering a remote role based in Wrocław for a Product Compliance Specialist focused on medical software compliance and information security within healthcare technology.

• Minimum 5 years of experience in Compliance, Information Security, Risk, or Governance, including projects with medical devices (SaMD)
• Documented experience in compliance assessment for medical products
• Practical knowledge of GDPR/RODO, including special category data processing and Privacy by Design/Default
• Knowledge of NIS2 and cybersecurity for critical entities
• Practical knowledge of ISO/IEC 27001 and ISMS maintenance
• Familiarity with SDLC, IEC 62304, ISO 13485, IEC 62366-1 standards
• Experience conducting gap analyses, compliance risk assessments, and remediation planning
• Experience creating and maintaining compliance documentation, policies, procedures, and audit materials
• Ability to cooperate with technical teams and translate regulatory requirements into practical solutions
• Understanding of distributed system architecture, IoT, cloud, and API integration affecting compliance
• Strong communication skills and experience presenting risks and recommendations to business and technical stakeholders
• English proficiency at B2/C1 level

Nice to have:

• Knowledge of MDR (EU 2017/745) and CE certification process for medical devices
• Familiarity with FDA requirements (21 CFR Part 820, Part 11)
• Knowledge of ISO 14971, ISO 27701, ISO 27017, ISO 27018
• Understanding HL7 and FHIR standards
• Experience working with notified bodies and conducting internal and external audits
• Industry certifications such as CIPP/E, CIPM, ISO 27001 Lead Auditor, Lead Implementer, CISA, CISM
• Experience in medical device cybersecurity
• Knowledge of DORA regulations
• Legal education or experience collaborating with legal departments

• Conduct compliance assessments for medical software products (SaMD)
• Evaluate solution compliance with GDPR/RODO, NIS2, ISO/IEC 27001, and medical software standards
• Perform gap analyses and risk assessments, prepare remediation plans
• Develop and maintain compliance documentation, policies, procedures, and audit materials
• Collaborate with architecture, engineering, QA, and business analysis teams on regulatory requirements implementation
• Support designing solutions according to privacy by design and security by design principles
• Monitor regulatory and standards changes and translate them into project requirements
• Advise business and technical stakeholders on compliance and regulatory risk management
• Participate in audit preparation and support cooperation with notified bodies