Head of Operations and Compliance / Head of Operations and Compliance

MYNERVA - Wyss Zurich

At MYNERVA – a Wyss Zurich project – our mission is to improve the lives of individuals suffering from neuropathy. We have developed a medical device designed to artificially restore the sense of touch and decrease pain through non-invasive neurostimulation.

Head of Operations and Compliance

We are seeking a highly driven Head of Operations and Compliance to lead our operational infrastructure, regulatory strategy, and quality systems as we prepare for clinical and commercial scale-up. This role is perfect for an experienced leader with a proven track record in operational excellence, medical device compliance, and international market readiness, particularly in the United States.

The Head of Operations and Compliance will oversee the full operational backbone of MYNERVA, including:

• Project management
• Supply chain
• Manufacturing
• Quality
• Regulatory affairs

This individual will collaborate closely with the executive team to build scalable processes and ensure that our products meet the highest standards of safety, efficacy, and compliance. The position is based in Zurich (100% on site).

Responsibilities

Operational Excellence

• Lead operational planning and execution with clear KPIs, timelines, and budgetary controls in coordination with other departments.
• Drive continuous improvement across operational workflows, cost control, and risk management.

Manufacturing & Supply Chain Management

• Set up and manage scalable manufacturing operations, including supplier management, to support clinical and commercial needs.
• Oversee procurement, production planning, and inventory management to ensure on-time delivery and quality.
• Monitor and optimize logistics and global distribution strategies.

Quality & Regulatory Compliance

• Guide the quality team in implementing a robust quality management system in accordance with ISO 13485, FDA QSR (21 CFR 820), and related standards.
• Provide oversight and guidance on regulatory strategy for the US (FDA) and international markets in collaboration with the regulatory and executive teams.
• Manage submissions with internal resources and outsourced consultants, including 510(k)s and IRBs.

Education & Experience

• Bachelor’s or Master’s degree in Engineering, Operations, Quality, Regulatory Affairs, or a related field.
• Minimum 5–7 years of experience in operations and compliance roles within the medical device industry.
• Proven experience with US FDA regulatory pathways and commercializing products in the US market.

Skills & Competencies

• Strong entrepreneurial approach.
• Solid understanding of medical device manufacturing and quality requirements.
• Strategic thinker with excellent execution, leadership, and organizational skills.
• Deep knowledge of international regulatory frameworks (FDA, ISO 13485).
• Familiarity with risk management, document control, and design controls.
• Strong communication and stakeholder management skills.
• Fluency in English; German or other languages are a plus.

Why Join MYNERVA?

• A high-impact role in a cutting-edge MedTech startup.
• Opportunities for fast-track career growth as MYNERVA scales.
• A highly motivated and collaborative team dedicated to improving patients’ lives.
• A dynamic, inclusive, and innovation-driven work environment.
• Benefits according to ETH Zurich’s employee benefits program.

Apply online using the form below. Please note that only applications matching the job profile will be considered.

For further information about MYNERVA, please visit our website. If you have any questions, feel free to reach out to Greta Preatoni at Show e-mail.

We would like to point out that the pre-selection is carried out by responsible recruiters and not by artificial intelligence. For recruitment services, the GTC of ETH Zurich apply.