Regulatory Specialist Diagnostics

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 products 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.

• 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 Systemand 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 workflowsand 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:

• Bachelors/Masters 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 atechnician 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 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.

Please read the Data Privacy Notice for further information about how we handle your personal data related to the recruitment process: we are

A healthier future drives us to innovate. Together more than 100000 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.

Lets build a healthier future together.