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The Position
We are looking for a Regulatory Affairs and Quality Specialist at Roche Diagnostics.
What will you do?
You ensure all product related local and global requirements for registration.
You supervise all kinds of registration procedures of the products, to obtain documentation related there of from company’s relevant global functions. Mastery of all IVD product local registration processes and coordination with functions such as product management, sales and tenders.
You coordinate regulatory documentation activities, obtain overseas documents required for tenders and other legal procedures and participate meetings with regulatory body when necessary.
You update and maintain the quality assurance system aligned with global standards and local requirements.
You work together with distributors in the quality assurance area and to perform controlling processes when necessary.
You prepare internal and external audits in collaboration with internal stakeholders and perform the action plans.
Who are you?
You have University Degree
You have Regulatory affairs and Quality experience in IVD/medical device industry
You have process knowledge and experience in ISO 9001 and ISO 13485 standards
You are experienced in conducting 2nd party audits & 3rd party logistics processes
You are proactive and team worker.
You are Fluent in English
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.