Regulatory Specialist Diagnostics

The Opportunity

As a Regulatory Specialist Diagnostics, you will be responsible for compiling 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 the success of the registration activities and strategies. Collaborates with other functions in the organization to obtain regulatory approvals for products with defined markets.

Provides 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. Interfaces 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. Maintain documentation of the Regulatory Information Management System and create and maintain product information on the Regulatory Information Management System. Create reports on Regulatory Information Management System. Responsible for maintenance of product technical files and for ongoing activities related to compliance with Global Regulatory directives and regulations. Support for documentation management system workflows and support for any appropriate submission activity, including PMA supplements, 30-day notices and certain 510(k). Support 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: 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.
• Flexibility: We also support flexibility to help you find your balance. Home office is commonly available (typically 2 office days/week on average, we provide fully remote working conditions within Hungary). We create the opportunity for freedom in working, where your corporate and private life coexist in harmony.
• A global inclusive 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.

Key skills/competency

• Regulatory Affairs
• Product Registration
• Regulatory Compliance
• Document Management
• Change Control
• Health Authority Liaison
• Technical Files
• Labeling
• International Submissions
• Diagnostics Regulation