Regulatory Lead, IVDR/MDR for Diagnostic Software

Hartwig Medical Foundation; Amsterdam; Hybrid; EUR 70,000 - 95,000; Full time

Benefits offered by this job

26 vacation days per year

Two-thirds pension contribution

Hybrid working environment

Generous office lunch

Access to professional development opportunities

Job summary

A non-profit organization dedicated to cancer care is looking for a Regulatory Compliance Officer in Amsterdam. This role entails overseeing IVD/MD compliance for software products and data-driven tools while collaborating with various stakeholders. Applicants should have a degree in life sciences or a related field and 5+ years in regulatory affairs, particularly IVDR/MDR. The position offers a competitive salary, flexible working hours, and opportunities for professional development.

Qualifications

• 5+ years in regulatory affairs or quality management, including 2+ years in IVDR/MDR.
• Solid understanding of IVDR/MDR regulations.
• Basic knowledge of software products and development processes.

Responsibilities

• Lead IVD/MD compliance for software products and tools.
• Coordinate the organization’s accreditation strategy.
• Oversee post-market surveillance and manage regulatory communications.

Skills

IVDR/MDR compliance

Regulatory affairs

Quality management

Strong communication

Education

Degree in life sciences, engineering, or related field

Job description

A non-profit organization dedicated to cancer care is looking for a Regulatory Compliance Officer in Amsterdam. This role entails overseeing IVD/MD compliance for software products and data-driven tools while collaborating with various stakeholders. Applicants should have a degree in life sciences or a related field and 5+ years in regulatory affairs, particularly IVDR/MDR. The position offers a competitive salary, flexible working hours, and opportunities for professional development.