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Medical Device Regulatory & Operations Director Europe

MyantRümlang, SwitzerlandOnsite

About Us


Myant is redefining how we connect with our bodies by integrating biometric monitoring capabilities into everyday textiles. Recently, Myant has acquired Nanoleq to fuel its European growth ambitions, leveraging Nanoleq’s advanced textile technology and Swiss engineering excellence to better serve healthcare providers and patients across the continent. As we expand our footprint and offerings, we seek a dedicated professional to help ensure regulatory compliance under MDR and build scalable operations supporting our sales efforts throughout Europe.

What We Offer


  • Impactful Work: Contribute to transformative technologies reshaping patient care and long-term health monitoring.
  • Career Growth: Become a key leader in establishing Myant’s European presence, gaining experience in both regulatory excellence and operational scaling.
  • Dynamic Environment: Work in a rapidly evolving, international setting with a multidisciplinary team of innovators dedicated to continuous improvement.
  • Competitive Compensation: Receive a comprehensive compensation package aligned with your expertise, along with opportunities for professional development and growth.

Role


The core responsibility of this role will be to lead and drive the MDR certification process for Myant’s cutting-edge monitoring solutions, ensuring full compliance with European medical device regulations. In addition to the regulatory focus, you will spearhead the development of a robust European sales organization—from crafting operational frameworks and processes to engaging with hospitals, cardiologists, and other healthcare stakeholders. While CRM (HubSpot) management and reporting form one part of this function, the greater focus will be on establishing the structures, workflows, and strategies that will support Myant’s commercial success in Europe.You will collaborate closely with two primary teams:

  • Regulatory Affairs (Canada): Reporting to and working alongside the Canadian-based regulatory affairs team for MDR and related compliance activities.
  • Sales & Operations (Europe): Supporting the European sales strategy under the guidance of the VP of Sales (based in Switzerland), orchestrating sales operations, building relationships, and enabling the market expansion efforts in hospitals and cardiology clinics.

Responsibilities:


  • MDR Certification & Compliance (Primary Focus):
  • Lead the end-to-end MDR certification process for Myant’s medical monitoring devices, coordinating with the Canadian regulatory affairs team.
  • Ensure all products meet applicable regulatory standards (e.g., MDR, ISO 13485) and maintain up-to-date technical documentation, risk management files, and clinical evaluation reports under Myant’s Quality Management System.
  • Act as the main liaison with European notified bodies, regulatory agencies, and external consultants, ensuring timely responses and adherence to evolving regulations.
  • European Sales Operations & Organizational Development:
  • Establish and refine scalable sales processes tailored to the European healthcare landscape, including hospitals and cardiology practices.
  • Develop infrastructure to support lead generation, customer engagement, account management, and distribution channels across Europe.
  • Manage and optimize CRM tools (e.g., HubSpot) as a component of a broader sales operations strategy—this includes training sales teams, ensuring data integrity, creating meaningful dashboards, and producing actionable insights.
  • Work closely with logistics, supply chain, and customer support teams to streamline order fulfillment, ensure efficient inventory management, and uphold a high standard of customer experience.
  • Serve as a strategic partner to the VP of Sales and local business units, providing operational guidance and recommendations for market entry, expansion, and customer retention strategies across multiple European markets.

  • Qualifications:


    • Education: Bachelor’s or Master’s degree in Biomedical Engineering, Regulatory Affairs, Life Sciences, Business, or a related field.
    • Regulatory Expertise: Demonstrated experience with medical device regulatory affairs and Quality Management Systems , particularly within the European MDR environment. Experience with ISO 13485 and CE marking is essential.Bonus for experience with the Swiss or UK regulatory environment.
    • Commercial & Operational Acumen: Proven track record in building or scaling sales operations in a healthcare/medical device environment, ideally involving hospitals and cardiologists as key clients.
    • Technical Knowledge: Familiarity with biosensing and wearable medical devices, digital health, and/or connected care solutions is a plus.
    • Communication & Collaboration: Excellent written and verbal communication skills in English; fluency in German or French is advantageous. Ability to manage cross-functional, international teams and multiple stakeholders.
    • Adaptability & Proactivity: Strong organizational and project management skills, with the capability to navigate a dynamic startup environment, implement new processes, and respond to regulatory and market changes proactively.

    If you’re ready to play a pivotal role in ensuring regulatory compliance while building the organizational backbone of Myant’s European sales efforts, we want to hear from you.

    Help us shape the future of connected care across Europe.


    Life at Myant

    Myant is an innovation hub for designing, developing and producing wearable technology. Our in-house team holds an array of talents, and are industry leaders in fashion design, chemistry, physics, software development and engineering, creating a diverse group of talent, with the expertise to deliver on any project. Together we believe in intelligently integrating and embedding technology into textiles in order to change how we live. Every project we create starts with a purpose. Whether it is to better connect with your environment, understand a customers activity, likes and dislikes, or add value to a garment through new utility; we are able to create an innovative and novel concept for a wearable product to meet your needs. There are no boundaries, only opportunities. Create the future of wearable technology with us.
    Thrive Here & What We Value1. Diverse, equal opportunity employer2. Paid Sick Days and Floating Days3. Group Health Insurance Plan4. RRSP matching Plan5. Corporate Events6. Exposure working in one of the most innovative and forward-thinking tech companies7. Multidisciplinary technology team solving big challenges at the intersection of electronics, deep tech., software, design, advanced manufacturing, and data science8. Access to state-of-the-art infrastructure at Myant Research Centre of Canada9. Innovative and forward-thinking tech company10. People with a disability or special accommodation request may send an email

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