Quality & Regulatory Affairs Manager

About the job

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-performing and pragmatic team with lots of creative freedom and direct influence on our quality management and proof of regulatory compliance of our products.

Your mission

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

You take on the role of management representative and are the responsible person for compliance with regulatory requirements (PRRC).

Among other things, you will take on:

⚙️ Maintaining and further developing the certified QM system ISO 13485

📄 Creating and maintaining the technical documentation

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

🏛️ First point of contact for audits by the Notified Body or regulatory authorities

🔧 Initiating and supporting the CAPA process, e.g. due to audit deviations

📊 Initiating and supporting post-market surveillance

🩺 Initiating and supporting the creation of clinical evaluations

🔎 Conducting supplier audits and controlling outsourced processes

⚠️ Contributing to the creation of the risk management file and the usability engineering file

👥 Close collaboration with product management and the Regulatory Affairs team at Straumann

Your profile

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

Ideally, you bring the following:

• Engineering degree or high-level technical training

• Experience in quality management and in the field of regulatory affairs for medical devices

• You find it easy to create new documents or maintain existing ones and to answer questions from
regulatory authorities correctly and efficiently

• Knowledge and corresponding implementation of regulatory requirements for medical devices
and audit experience with authorities

• Very good German and English skills

What to expect from us

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

Workplace: Berneck SG and/or home office

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