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Regulatory affairs manager

Volketswil
Hocoma
EUR 100’000 - EUR 125’000 pro Jahr
Inserat online seit: 13 Juli
Beschreibung

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Global Talent Acquisition Partner at DIH Technology Co. DIH stands for the vision to “Deliver Inspiration & Health” to improve the functioning of millions of people with disability and functional impairments. DIH is a global solution provider in blending innovative robotic and virtual reality (“VR”) technologies with clinical integration and insights. Built through the mergers of global-leading niche technologies providers, DIH is positioning itself as a transformative total smart solutions provider and consolidator in a largely fragmented and manual-labor-driven industry.
Join us and be part of a global network of leading brands committed to redefining the rehabilitation therapy standards of today and tomorrow!
Role
Your will be a key employee to drive the company forward and to help expanding our business. You know the development potential of our innovative medical high-tech devices in the neurorehabilitation market and applies his/her profound knowledge in the field of international regulations and standards for medical devices. The jobholder is responsible for coordinating and monitoring our product registrations worldwide. In the interface with quality management, product management and our partners worldwide, he/she creates the technical product documentation. You also organizes national adaptations of existing product registrations in case of product changes.
Responsibilities
Performing submissions by preparing and providing required documentation and deficiency responses to achieve medical device registrations internationally
Provide reliable regulatory guidance in development projects.
Support sustaining engineering with regulatory inputs derived from norms, guidance docs, etc. throughout the life cycle of assigned devices.
Create and maintain device-specific STED documentation.
Provide input to achieve compliance with all regulatory requirements for assigned projects.
Policy monitoring to obtain up-to-date knowledge in quality and product relevant standards, laws and guidelines, with feedback into the department, or overall organization, as relevant.
Sustainable integration of a living Post Market Surveillance System at all DIH Rehabilitation Solution locations, taking into account the data flow from all Hocoma Hubs
Support the quality team in product and process audits.
Requirements
3+ years of relevant work experience in a medical device company
Previous proven experience in industry with requirements such as ISO 13485, MDR, QSR, 510k
Self-driven, highly goal-oriented and independent personality
Excellent interpersonal and communication skills, and the ability to perform in a complex, global environment
Excellent problem solving and negotiation skills
Very good English language skills, other languages are an asset
At DIH people are driven by dedication. We make a difference.
We offer an exciting and collaborative working environment with a lean hierarchy, open communication and high employee participation.
Our business is growing, and we are always on the search for talented people looking to change people’s lives for the better.
Please include your motivation letter that points out why you match with us, and your resume when applying on our website.
If you have any questions, please reach out to Ying Zhang, Global Talent Acquisition Partner: ying.zhang@dih.com
Seniority level Seniority level Associate
Employment type Employment type Full-time
Job function Job function Other
Industries Medical Equipment Manufacturing
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