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.
As a Regulatory Specialist you will be responsible to compile documents and deliverables to support planned product registration timelines. You will maintain product registration throughout a product’s lifecycle by applying successful regulatory change control. You will maintain clear agreement with other functions, stakeholders, and external partners (such as health authorities, companies, and notified bodies) to promote success of the registration activities and strategies. Collaborates with other functions in the organization to obtain regulatory approvals for products with defined markets.
The Opportunity:
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.
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.
Maintaining documentation of the Regulatory Information Management System and creating and maintaining product information on the Regulatory Information Management System
Creating reports on Regulatory Information Management System
Being responsible for maintenance of product technical files and for ongoing activities related to compliance with Global Regulatory directives and regulations
Supporting documentation management system workflows and supporting any appropriate submission activity, including PMA supplements, 30-day notices and certain 510(k)
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
Bachelor's/Master's degrees or equivalent experience
0-5 years experience, in Regulatory, R&D, Quality, Operations and/or Clinical
Equivalent experience" may be satisfied by having completed training as a technician, a laboratory technician, or an equivalent qualification
Fluent in English, German is a plus
Proven ability to work autonomously
In exchange we provide you with
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.
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).
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
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.
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.
Roche is an Equal Opportunity Employer.
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