Quality & Regulatory Affairs Manager

Do you want to combine quality management and regulatory affairs and take responsibility for the regulatory compliance of our medical devices?

Then become part of GalvoSurge Dental AG – a dynamic medtech company within the Straumann Group, a world-leading provider in the dental industry.

With us, you will work in a small, high-performance and pragmatic team with a lot of creative freedom and direct influence on our quality management and the demonstration of regulatory compliance of our products.

Your Mission

You ensure our existing quality management system, develop it further, and independently handle all regulatory topics surrounding our two product families.

You assume the role of the person appointed by management and are the responsible person for compliance with regulatory requirements (PRRC).

In doing so, you will undertake, among other things:

?? Maintenance and further development of the certified QM system ISO 13485

?? Creation and maintenance of the technical documentation

??? Ensuring that all GalvoSurge products meet the applicable regulatory and normative requirements

??? Primary contact person during audits by the Notified Body or regulatory authorities

?? Initiate and accompany the CAPA process, e.g., due to audit deviations

?? Initiate and support Post-Market Surveillance

?? Initiate and support the creation of clinical evaluations

?? Conducting supplier audits and controlling outsourced processes

?? Participation in the creation of the risk management file and the Usability Engineering File

?? Close cooperation with product management and the Regulatory Affairs team from Straumann

Your Profile

You are a structured, responsible personality who enjoys working independently and efficiently advances regulatory and quality-related topics.

Ideally, you bring the following:

• Engineering studies or technical training at a high level
• Experience in quality management and in the area of regulatory affairs for medical devices
• You find it easy to create new documents or maintain existing documents as well as to answer questions from regulatory authorities correctly and efficiently
• Knowledge and corresponding implementation of the regulatory requirements for medical devices and audit experience with authorities
• Very good German and English skills

What awaits you with us

? Working in an agile medtech company with short decision-making paths
? Direct influence on products and production processes
? Cooperation with an internationally leading dental company
? Flexible home office component
? 60–100% workload

Work location: Berneck SG and/or home office

?? Please note: We only consider direct applications (no recruitment agencies).

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