Global Regulatory Documentation Specialist

Kelly Science, Engineering, Technology & Telecom; Polska; In loco; PLN 90.000 - 135.000; Tempo pieno

Descrizione del lavoro

Kelly Science, Engineering, Technology & Telecom in Poland is seeking a Regulatory Affairs Documentation Specialist to support a global medical technology program. You will manage regulatory documentation, labeling materials and submission publishing within an international team.

The role emphasizes accuracy, organised processes, and collaboration across regions, with a 12-month fixed-term contract under an outsourced service model.

Competenze

• Experience in regulatory documentation lifecycle.
• Familiarity with MDR and EU medical device regulations.
• Excellent attention to detail and organisational skills.

Mansioni

• Prepare, coordinate, dispatch and file routine regulatory documentation.
• Coordinate submissions and labeling activities.
• Publish and manage documents in electronic systems and ensure records are current.
• Support regulatory tracking, metrics and reporting to enable operations insight.

Conoscenze

Regulatory documentation

Document control

Quality systems

Regulatory submissions

Word/Excel proficiency

Strumenti

QUMAS

Agile

MDRIM

Descrizione del lavoro

Kelly Science, Engineering, Technology & Telecom in Poland is seeking a Regulatory Affairs Documentation Specialist to support a global medical technology program. You will manage regulatory documentation, labeling materials and submission publishing within an international team.

The role emphasizes accuracy, organised processes, and collaboration across regions, with a 12-month fixed-term contract under an outsourced service model.