Medical Device QA & Regulatory Compliance Analyst

Hitachi Vantara Corporation; Kraków; On-site; PLN 120,000 - 160,000; Full time

Job summary

A leading medical technology organization in Kraków seeks a Quality Assurance Specialist with experience in regulated industries. Responsibilities include leading documentation reviews, ensuring compliance with regulations, and advising R&D teams. The ideal candidate will have a strong background in medical device regulations and risk management. The role is crucial for ensuring product effectiveness and regulatory submissions.

Benefits

Culture of caring

Learning and development opportunities

Work-life balance options

High-trust organizational environment

Qualifications

• 2-3 years of experience in a quality role within regulated industries.
• Understanding of medical device regulations.
• Experience in conducting internal/external audits.

Responsibilities

• Lead review and approval of project documentation.
• Assess project activities against established procedures and standards.
• Advise the R&D team on process adjustments.

Skills

Quality system knowledge

Risk Management

Regulatory knowledge

Communication skills

Organizational skills

Education

Bachelor's or Master's Degree in engineering

Job description

A leading medical technology organization in Kraków seeks a Quality Assurance Specialist with experience in regulated industries. Responsibilities include leading documentation reviews, ensuring compliance with regulations, and advising R&D teams. The ideal candidate will have a strong background in medical device regulations and risk management. The role is crucial for ensuring product effectiveness and regulatory submissions.