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Director of Regulatory Affairs and Quality Assurance

Remote:

Full Remote

Experience:

Expert & Leadership (>10 years)

Work from:

Switzerland

Offer summary

Qualifications:

Degree in a relevant discipline., Solid experience in Regulatory Affairs., Experience with class III medical devices., Knowledge of FDA and CE approvals., Understanding of ISO 13485..

Key responsabilities:

Develop regulatory strategies for approvals.
Oversee submissions for regulatory clearance.

Guided Solutions SME

11 - 50 Employees

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Job description

Your missions

For our client based in Switzerland, we are looking for an experienced professional for the role of Director of Regulatory Affairs and Quality Assurance.

The main responsibility will be the regulatory strategies and submissions necessary to obtain regulatory clearance and approval (FDA, following CE).

Please note this is not a people management position. It is an individual contributor role.

Requirements

A degree in a relevant discipline.
Solid experience in Regulatory Affairs and Quality Assurance of class III medical devices.
Experience in leading RA/QA activities at a clinical stage of product development for FDA approval (essential) and CE approval.
Detailed understanding of ISO 13485.
Managerial experience is preferred.
Strategic thinking and leadership skills
Excellent English language is essential.