Regulatory Affairs and Quality Specialist

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

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

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.