- 80 - 100%
Team Leader Regulatory Affairs 80 - 100% (w/m/d)
Hamilton Medical is a dynamic, internationally successful medical device company headquartered in Bonaduz, Switzerland. At Hamilton Medical, we live for ventilation technology. Technology that helps caregivers improve the lives of their critically ill patients. We believe that innovation is essential to meet the demands of critical care.
To strengthen our multinational team, we are looking for motivated people in all areas of the company: from software developers to medical or healthcare professionals, from engineers to export specialists, from production workers to regulatory affairs specialists, and from project leaders to product managers.
Help us to get our innovative medical devices approved quickly and safely and to master regulatory challenges over the long term.
Leading a team of regulatory affairs managers with four employees
Define regulatory strategy and requirements in support to new product introduction and lifecycle management projects
Checking the completeness and correctness of project documentation/test reports from a regulatory point of view
Communication with external parties e.g. certified and notified body
Preparation and maintenance of the Technical Documentation (EU/MDR)
Submission and maintenance of approvals in Europe, USA and Canada
Evaluation of substantial changes on existing approvals
Support for the team Regulatory International for other international approvals
Participation in reviews of product labelling documentation (manuals, brochures, websites, etc.)
Collaboration in the implementation of new standards and regulations within Hamilton Medical AG
Preparation and maintenance of various regulatory overviews and trainings for other departments
Professional experience in regulatory affairs
Leadership skills and team oriented
Strong communicator both within the team and between interfaces
Experience with approvals under MDR and preparation of technical documentation
Experience with international approvals (e.g. FDA)
Technical or scientific FH/HS degree
Fluent in English and German
Comprehensive induction and training in the area of regulatory
A diverse job with exciting challenges
A high degree of personal responsibility and plenty of room for your personal development
Flexible working time models and modern workplaces with good transport connections
Possibility for up to 20% home office
Advanced social benefits
Participation in education and training
Are you interested? Then please apply online by clicking on the "Apply" button. There you will also find our contact details for any queries.
Applications by post or e-mail can unfortunately not be considered.