Global Regulatory Affairs Manager - Medical Devices

Teleflex; Bülach; On-site; CHF 90,000 - 130,000; Full time

Job summary

Teleflex Incorporated in Switzerland seeks a Regulatory Affairs professional to ensure that vascular intervention medical devices are developed, manufactured, and distributed in strict compliance with global healthcare laws and for submissions in Europe, the US, and Canada.

You will assess design and manufacturing changes for regulatory impact, coordinate worldwide change assessments, and maintain regulatory documentation up to date.

Qualifications

• University degree in natural science, pharmacy, pharmacology, medicine or engineering.
• Fluency in English is mandatory.
• Experience with regulatory registration of medical devices is preferred.

Responsibilities

• Assess design and manufacturing changes to ensure regulatory compliance and that information is available for regulatory impact assessment.
• Coordinate and contribute to worldwide assessment of changes and support lifecycle activities.
• Maintain regulatory documentation up to date for worldwide regulatory purposes.
• Support the registration of changes for class II and III devices in CE, US, Japan and other highly regulated countries.
• Coordinate and submit deficiency responses to relevant certification bodies and country authorities.

Skills

Fluent English

Team collaboration

Attention to detail

Analytical skills

Education

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

Tools

Microsoft Office

Adobe Acrobat

Job description

Teleflex Incorporated in Switzerland seeks a Regulatory Affairs professional to ensure that vascular intervention medical devices are developed, manufactured, and distributed in strict compliance with global healthcare laws and for submissions in Europe, the US, and Canada.

You will assess design and manufacturing changes for regulatory impact, coordinate worldwide change assessments, and maintain regulatory documentation up to date.