Regulatory Expert

THAUMATEC TECH GROUP; Wrocław; On-site; PLN 179,000 - 273,000; Full time

Job summary

THAUMATEC TECH GROUP is seeking a regulatory compliance specialist for medical software to ensure development, documentation and lifecycle management meet MDR, FDA and international standards.

You will maintain and extend the Technical File and Design History File, prepare MDR/IVDR and FDA documentation, support risk management and cybersecurity assessments, and collaborate with developers, testers and architects to prove compliant processes.

Qualifications

• Higher technical education in a related field.
• 2+ years in software quality assurance or regulatory compliance.
• Familiar with medical software lifecycle and risk management.
• Proficient with quality documentation and standards.

Responsibilities

• Prepare regulatory documentation for MDR/IVDR and FDA requirements.
• Ensure lifecycle alignment with IEC 62304, ISO 13485, ISO 14971, IEC 81001-5-1 and internal QMS.
• Maintain and enhance the QMS; support safety and cybersecurity assessments.
• Assist with software verification/validation and establish traceability.
• Collaborate with developers/testers/architects to prove process compliance.
• Review documentation sets and act as a key reviewer.

Skills

Regulatory compliance

Software quality assurance

Documentation

Risk management

Cybersecurity awareness

English communication

Education

Biomedical engineering

Computer science

Automation

Tools

e-QMS

Quality documentation tools

Job description

We are looking for a candidate to take responsibility for the regulatory compliance of our medical software. This involves ensuring that the software is developed, documented, and maintained in accordance with applicable regulatory requirements (FDA, EU MDR) and international standards, with a specific focus on maintaining the integrity of the Technical File and the Design History File.

Key Responsibilities

• Preparing regulatory documentation in accordance with MDR/IVDR and FDA requirements.
• Ensuring the software life cycle aligns with standards such as IEC 62304, ISO 13485, ISO 14971, IEC 81001-5-1, and related standards, as well as our internal QMS.
• Maintaining and enhancing the QMS.
• Preparing documentation for safety risk management and cybersecurity management processes, especially performing safety risk assessments and cybersecurity threat assessments.
• Assisting with software verification and validation, ensuring full traceability from requirements to results.
• Collaborating with developers, testers, and architects to ensure project and release compliance, while gathering evidence that proper processes are followed.
• Acting as a key reviewer for the whole documentation set.

Qualifications Required

• Possess a higher technical education, such as biomedical engineering, computer science automation, or a related field.
• Hold a minimum of two years of experience in software quality assurance or regulatory compliance within the medical device or IVD industry.
• Demonstrate familiarity with the medical software lifecycle and risk management principles.
• Proficient in working with quality documentation and standards.
• Communicate fluently in English (B2/C1) in an international environment.
• Adopt a proactive approach to support input gathering and regulatory process execution.
• Efficiently manage input collection, documentation development, review, and approval processes.

Preferred

• Knowledge of cybersecurity issues and regulations related to AI in healthcare.
• Experience working with SaMD (Software as a Medical Device), medical devices with software, or IVD systems.
• Understanding of audit processes and software verification principles.
• Experience in technical writing.
• Familiarity with a CCMS or e-QMS is a plus.
• IREB certification is a plus.

Salary

• UoP - 16 000 - 20 500 zł
• B2B - 18 000 - 24 500 zł