Description

You will manage regulatory compliance and reporting for medical and pharmaceutical products, ensuring alignment with established standards.

Responsibilities

• Manage regulatory reporting processes to ensure ongoing compliance for IVD and pharmaceutical products.
• Maintain alignment with all established regulatory requirements and documentation workflows.
• Support compliance workflows for In Vitro Diagnostics (IVD) and pharmaceutical product lines.
• Execute regulatory reporting tasks using PAC systems.

Required Skills

• 5+ years of experience in regulatory affairs.
• Knowledge of In Vitro Diagnostics (IVD) regulations.
• Experience with European Union regulatory standards.
• Background in Biomedical Engineering or general Engineering.
• Familiarity with Pharmaceuticals.
• Experience with PAC.
• Ability to manage regulatory reporting tasks.

Preferred Skills

• Any Graduate education in a relevant engineering discipline.

Key Skills

Education

Any Graduate