Regulatory Affairs Associate – Medical Devices (Global)

Teleflex; Zürich; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

Teleflex in Zürich, Switzerland seeks a Regulatory professional to ensure vascular intervention medical devices are developed, manufactured and registered in line with global healthcare laws. You will manage regulatory assessments of changes and maintain worldwide documentation.

Responsibilities include design/manufacturing change assessment, supporting CE/US/Japan registrations, coordinating deficiency responses, and keeping documentation up to date.

Qualifikationen

• University degree in natural science, pharmacy, pharmacology, medicine or engineering.
• At least 2 years of experience with registration of medical devices and regulatory assessment of changes in Europe and other highly regulated countries.
• Fluency in English is mandatory; literate in Microsoft Office and Adobe Acrobat.

Aufgaben

• Assess design and manufacturing changes for regulatory impact and compliance.
• Coordinate worldwide assessment of changes and support product lifecycle activities.
• Maintain regulatory documentation up to date for worldwide purposes.
• Support registration of changes for class II and III devices (CE, US, Japan, etc.).
• Coordinate and submit deficiency responses to authorities and certification bodies.

Kenntnisse

Regulatory knowledge

Attention to detail

Analytical skills

Multidisciplinary teamwork

Project management

Ausbildung

University degree in natural science, pharmacy, pharmacology, medicine or engineering

Tools

Microsoft Office

Adobe Acrobat

Jobbeschreibung

Teleflex in Zürich, Switzerland seeks a Regulatory professional to ensure vascular intervention medical devices are developed, manufactured and registered in line with global healthcare laws. You will manage regulatory assessments of changes and maintain worldwide documentation.

Responsibilities include design/manufacturing change assessment, supporting CE/US/Japan registrations, coordinating deficiency responses, and keeping documentation up to date.