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. MYNERVA has developed a medical device designed to artificially restore the sense of touch and decrease pain using non-invasive neurostimulation.

About the Role

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 ideal for an experienced leader with a strong track record in operational excellence, medical device compliance, and international market readiness, particularly in the United States.

The Head of Operations and Compliance will be responsible for overseeing the full operational backbone of MYNERVA, including project management, supply chain, manufacturing, quality, and 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).

Key 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:
  • Establish 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 robust quality management systems in accordance with ISO 13485, FDA QSR (21 CFR 820), and related standards.
  • Provide oversight and guidance for regulatory strategy for the US (FDA) and international markets in collaboration with the regulatory and executive team.
  • Manage submissions alongside internal resources and outsourced consultants such as 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.
• In-depth 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).

What We Offer

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

We look forward to receiving your online application using the form below. Please ensure that your application includes the following documents:

• Video pitch introduction (compulsory, 1 min max)
• CV
• Motivation letter: why MYNERVA?
• Reference letters

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, do not hesitate to reach out to Greta Preatoni at Show e-mail.

We would like to point out that the pre-selection is carried out by the responsible recruiters and not by artificial intelligence.

For recruitment services, the GTC of ETH Zurich apply.