Senior Manager Regulatory Affairs - Zurich

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Quality & Regulatory Affairs Manager (60–80%) – Software as a Medical Device (SaMD) · Location: · Zurich · Employment Type: · (60–80%) · We are hiring on behalf of a client · Our client is an innovative MedTech start-up developing cloudbased, AI-powered preprocedural planning ...

Jobbeschreibung

Quality & Regulatory Affairs Manager (60–80%) – Software as a Medical Device (SaMD)

Location:
Zurich

Employment Type:
(60–80%)

We are hiring on behalf of a client

Our client is an innovative MedTech start-up developing cloudbased, AI-powered preprocedural planning software for structural heart disease interventions, as well as digitaltwin–based predictive medicine platforms for cardiovascular treatment planning.

Their young, multidisciplinary team is committed to transforming medical image processing and treatment planning workflows.

They are now seeking an experienced Quality & Regulatory Affairs Manager to lead and expand their quality and regulatory framework for their Software as a Medical Device (SaMD) portfolio.

Your Role

As the Quality & Regulatory Affairs Manager, you will take ownership of the company's ISO 13485 Quality Management System, drive regulatory strategy across major markets, ensure compliance with key standards, and collaborate closely with engineering and product teams to guarantee that the software is safe, effective, and compliant.

Key Responsibilities

Lead regulatory strategy and execution for SaMD products in the US, EU, and priority global markets, including documentation and regulatory submissions.

Maintain, update, and continuously improve the ISO 13485 Quality Management System.
Ensure alignment with FDA and EU MDR requirements for SaMD.
Integrate ISO 14971 risk management and design controls into the software development lifecycle in collaboration with engineering teams.
Implement and maintain compliance with ISO 17025 and ISO 5840 for testing laboratories, verification/validation, and evidence-generation processes.
Prepare for and host internal and external audits; manage findings and drive CAPA and continuous improvement initiatives.
Lead supplier and partner qualification (including cloud/IT, development partners, and testing labs) and manage supplier quality agreements.
Oversee clinical evaluation, postmarket surveillance, complaint handling, and vigilance reporting for SaMD products.
Train and support cross-functional teams to promote a strong quality culture within the company.
Your Profile
Degree in engineering, life sciences, computer science, or a related field.

8+ years of experience in quality and regulatory roles within the medical device industry, ideally with a strong focus on SaMD.

Proven experience with FDA Class II devices — 510(k), De Novo, or equivalent submissions.
Experience with EU MDR Class I devices, including technical documentation, PMS/PMCF, clinical evaluation, and interactions with Notified Bodies.
Hands-on experience establishing or managing an ISO 13485 QMS, preferably in a startup or fastscaling environment.
Experience implementing and maintaining ISO 17025 related to testing labs, validation, or verification processes.
Familiarity with IEC 62304, HIPAA requirements, and cybersecurity considerations relevant to SaMD.
Experience preparing for and supporting external audits (FDA, Notified Bodies, ISO certification).