Regulatory Affairs Associate, Medical Devices (Contract)

Teleflex; Bülach; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Zusammenfassung

Teleflex is seeking an Associate Regulatory Affairs Specialist (3-year contract) to ensure medical devices are developed, manufactured and registered in Europe, US and Canada.

The role coordinates regulatory changes, maintains documentation, and supports CE/US/Japan registrations. Fluency in English is mandatory; university degree in a relevant field required; strong organizational and cross-functional collaboration skills are essential.

Qualifikationen

• University degree in natural science, pharmacy, pharmacology, medicine or engineering.
• Experience with regulatory registration of medical devices in Europe or other regulated markets.
• Proficient with MS Office and Adobe Acrobat for documentation and submissions.
• Strong communication and cross-functional teamwork abilities.

Aufgaben

• Assess design/manufacturing changes for regulatory impact and documentation.
• Coordinate worldwide assessment of changes and related lifecycle activities.
• Maintain regulatory documentation up to date for global purposes.
• Support registration of changes for class II/III devices (CE/US/Japan).
• Coordinate and respond to deficiency requests from authorities.

Kenntnisse

English fluency

Regulatory affairs

Team collaboration

Attention to detail

Analytical skills

Microsoft Office

Adobe Acrobat

Ausbildung

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

Tools

Microsoft Office

Adobe Acrobat

Jobbeschreibung

Teleflex is seeking an Associate Regulatory Affairs Specialist (3-year contract) to ensure medical devices are developed, manufactured and registered in Europe, US and Canada.

The role coordinates regulatory changes, maintains documentation, and supports CE/US/Japan registrations. Fluency in English is mandatory; university degree in a relevant field required; strong organizational and cross-functional collaboration skills are essential.