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.

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.
 

This role involves collaborating with the Legal Manufacturer and Suzhou Sub-Chapter team to support our affiliates in obtaining the regulatory documents, such as clinical and non-clinical studies, manufacturing flowcharts, and labeling materials, among others. Additionally, you will review statements and facilitate signature coordination across all business areas in the Roche Diagnostics Division.

This opportunity extends beyond the assignment, offering avenues to expand your professional network, explore a new field, and refine your interpersonal skills through interaction with various affiliate teams.

The Opportunity

Assist in activities associated with regulatory approval of in vitro diagnostic medical devices in global markets.

Provide support to currently marketed products, e.g., review engineering changes, labeling, promotional material, product changes, and documentation for compliance and changes requiring regulatory agency approval, as pertains to US and international regulatory requirements.

Responsible for the maintenance of product technical files and ongoing activities related to compliance with global directives and regulations.

Assist in submission activities for a variety of device regulatory approvals, including the CE mark, US premarket approvals (PMAs), US premarket notifications (510(k)s), post-approval reports, export certificates, establishment registrations and listings, etc.

Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and discipline as relevant to assigned projects.

Interface with regulatory authorities on regulatory and technical matters, as directed.

May provide regulatory support on project teams and may assist in the review of proposed device changes.

Assist in the creation of Operating Procedures and policy guidelines.

Assist in review of labeling changes, advertising and promotional activities, etc.

May assist as the internal regulatory consultant for on-market product issues.

Who You Are

You have a B.S./B.A. in a science, engineering, or related technical field; an advanced degree is preferred.

You have 0-5 years of experience in regulatory, development, clinical affairs, quality, or program management in IVD, medical device, or pharma industries. Regulatory affairs experience is preferred. IVD device experience is preferred.

Preferred Experience:

Experience with regulatory submissions, including IDE, 510(k), and PMA submissions, is preferred.

Experience working in a cross-functional team setting is preferred.

Regulatory Affairs Certification preferred.

Location: Avinguda de la Generalitat, 171, 173, 08174 Sant Cugat del Vallès, Barcelona, Spain.

Relocation assistance and Remote work arrangements are not available for this opportunity.

Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. 

A discretionary annual bonus may be available based on individual and Company performance. 

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.