Regulatory Specialist Diagnostics (Maternity cover)

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

The Opportunity:

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.

• 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).

• 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: https://go.roche.com/budapest->A healthier future drives us to innovate. Together, more than 100’000 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.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.