Head of Quality and Regulatory Affairs

Einleitung

Medicaroid is a Japan based medical device company founded 2013 with its global Headquarter in Kobe. We are looking for a motivated employee based in our Headquarter in Düsseldorf which has been established in 2020. You want to be a member of a startup team to change the world of robotic surgery? If so, you´re welcome to join our European Medicaroid team.

As the Head Regulatory affairs and of Quality Management, you will be an integral part of supervising the regulatory and quality matters at Medicaroid hinotoriTM robotic surgery system. You will be responsible for managing the team and drive results in accordance with MDR (Medical Device Regulation 2017/745) and ISO 13485 requirements. This role will involve all topics which are related to the regulatory and quality environment including the support for joint development of devices as quality and regulatory expert. You will collaborate with other departments, such as Medical, Commercial, Customer Support & Service, Logistics, Alliance & Engineering, Training/Education and Marketing. Furthermore, you will have a close collaborative relationship with our Japanese Headquarter. This role will be reporting to the medical director.  

Ihre Aufgaben

• Cover the PRRC role when requested from the needs of the company (e.g. during the absence of the current PRRC)
• Develop and execute regulatory strategies for products and services
• Provide regulatory expertise for complex or unique issues and challenges regarding registration and compliance activities.
• Reviews, interprets, and communicates Notified Body/international regulations and guidance documents to ensure complete and scientifically sound documentations and submissions
• Prepare pre/post market reports / technical and clinical documentation per the requirements of key regulatory agencies (e.g. Notified Body, Competent Authorities and other regulatory authorities in the EMEA region).
• Coordinate regulatory issue resolution using internal resources, regulatory agencies, and external consultants as needed
• Promote excellence and innovation by conducting trainings and/or communicate appropriate materials to enhance the knowledge of the team
• Work closely with the HQ based in Japan
• Act as the regulatory expert and point of contact for internal and external parties
• Lead the preparation and maintenance of plans and annual reports in accordance with MDR (Medical Device Regulation 2017/745) and ISO 13485 requirements
• Oversee the QMS to ensure compliance with quality standards
• Take accountability, lead and manage the quality and regulatory affairs team, ensuring drive, high quality output, wellbeing and development of the staff
• Collaborate closely with the medical director to ensure compliance and success of the KPIs of the company
• Drive interdisciplinary collaborations within the company to align business needs and ensure scientifically robust and compliant strategies.
• Manage timelines, budgets forecast and resource allocation according to requirements of the business.

Ihr Profil

• **MUST have: Proven experience as PRRC (**Application cannot be considered without PRRC experience.)
• Bachelor’s degree in a scientific, medical, or technical discipline
• Minimum of 7 years’ experience in managing a multi-disciplinary regulatory and quality team, or regulatory and quality teams cumulative experience
• Extensive experience in healthcare and medical devices EU regulatory frameworks
• Deep knowledge of QMS, product safety laws, operational quality, and global market regulatory requirements
• Deep knowledge on relevant regulatory requirements such as GCP (Good Clinical Practice), ISO 14155, MDR (Medical Device Regulation 2017/745), MEDDEV 2.7/1 rev.4 and ISO 13485
• Knowledge of audit processes
• Ability to lead projects to success
• Ability to deliver clear relevant information and foster multi-disciplinary collaboration within the organisation
• Ability to work under pressure, identifying priorities and complete tasks and projects within the deadlines
• Ability to communicate and escalate appropriately through the chain of command in a timely fashion
• B2 verbal and written English required
• C1 verbal and written German Required
• Work at office/training centre based in Düsseldorf.
• Personal motivation and striving for improvement and development

Wir bieten

• Our organizational structure is built around collaborative, cross-functional teams, enabling short decision-making paths and a strong partnership-driven culture.
• We take work–life balance seriously and provide flexible working conditions that support both professional and personal needs.
• We are an innovative company with a start-up mindset, offering the opportunity to actively shape structures, processes, and milestones.
• We offer you a key role with a high degree of autonomy and impact
• The opportunity to build and shape the finance function from the ground up
• Competitive compensation and long-term development prospects
• Flexible working arrangements and a modern work environment
• Talent development is a priority, supported through close collaboration between management, functional departments, and Human Resources.
• We strongly believe in lifelong learning and view continuous professional development as a core element of our culture.
• Employee well-being matters to us — we actively promote health initiatives, including a weekly fresh fruit delivery to support a healthy work environment.
• You will benefit from 30 days of annual leave, in addition to company holidays on carnivals „Rosenmontag “, on Christmas Eve, and on New Year’s Eve.

Weitere Informationen

Medicaroid Europe GmbH   

Wanheimer Str. 90-92
40468 Düsseldorf