Hungary Job Openings

Roche
Regulatory Specialist Diagnostics
Budapest
FULL TIME
November 20, 2024
The Opportunity:
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Providing support to currently marketed products, e.g., labeling, product and manufacturing changes and documentation for compliance and for changes requiring regulatory agency approval, as pertains to regulatory requirements. This includes annual reporting and laser reporting in relevant countries.
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Interfacing with internal stakeholders to collect data to prepare, maintain regulatory documentation. This includes internal documentation decisions and review of analytical data report review and authoring of relevant analytical documentation.
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Maintaining documentation of the Regulatory Information Management System and creating and maintaining product information on the Regulatory Information Management System
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Creating reports on Regulatory Information Management System
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Being responsible for maintenance of product technical files and for ongoing activities related to compliance with Global Regulatory directives and regulations
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Supporting documentation management system workflows and supporting any appropriate submission activity, including PMA supplements, 30-day notices and certain 510(k)
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Supporting international regulatory submissions by provision of needed data and documents; answering Health Authority questions on the submissions; keeping our Affiliates informed about new products /projects/ process changes etc.
Who you are
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Bachelor's/Master's degrees or equivalent experience
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0-5 years experience, in Regulatory, R&D, Quality, Operations and/or Clinical
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Equivalent experience" may be satisfied by having completed training as a technician, a laboratory technician, or an equivalent qualification
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Fluent in English, German is a plus
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Proven ability to work autonomously
In exchange we provide you with
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Development opportunities: Roche is rich in learning resources. We provide constant development opportunities, free language courses & training, the possibility of international assignments, internal position changes and the chance to shape your own career.
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Excellent benefits & flexibility: competitive salary and cafeteria package, annual bonus, Private Medical Services, Employee Assistance Program, All You Can Move Sportpass, coaching / mentoring opportunity, buddy program, team buildings, holiday party. We also ensure flexibility, to help you find your balance: home office is a common practice (2 office days/week, and we provide fully remote working conditions within Hungary).
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A global diverse community, where we learn from each other. At Roche, we cooperate, debate, make decisions, celebrate successes and have fun as a team. Our leadership is very focused on people, creating a strong, inclusive culture, so you always have the chance to share your opinion.
Please read the Data Privacy Notice for further information about how we handle your personal data related to the recruitment process: https://go.roche.com/budapest-data-privacy-notice-candidate
The Roche Services & Solutions as well as People Support Solutions organisations located in Budapest provide end-to-end business solutions for Finance, Procurement, IT, Communications, People & Culture (Human Resources) and beyond to our Roche colleagues across the EMEA region. Today Roche employs altogether around 2000 employees in Hungary.
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