Medical Device Regulatory & Operations Director Europe

Job Detail

Job-ID 340491

Job-Beschreibung

About UsMyant 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.

RoleThe 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.Powered by JazzHR