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 play a crucial role in compiling documents and deliverables to support planned product registration timelines. You will manage product registrations throughout their lifecycle by applying successful regulatory change control. Collaborating with various functions, stakeholders, and external partners, you will help ensure the success of our registration strategies and activities.

Key Responsibilities:

Provide support to currently marketed products, including labeling, product and manufacturing changes, and documentation for compliance.

Collect data and prepare regulatory documentation in collaboration with internal stakeholders.

Maintain and manage the Regulatory Information Management System.

Create reports and maintain product technical files for compliance with global regulatory directives.

Support submission activities, including PMA supplements, 30-day notices, and certain 510(k) submissions.

Assist with international regulatory submissions and answer Health Authority queries.

Qualifications:

Bachelor’s degree or equivalent experience.

2-5 years of experience in Regulatory, R&D, Quality, Operations, and/or Clinical.

Knowledge of global regulatory requirements, guidelines, and procedures especially for In Vitro Diagnostic or Medical Device instruments & software

Demonstrated proficiency in English, both written and verbal, with the ability to communicate effectively in a professional setting.

Proven ability to work autonomously.

Mindset:

At Roche Diagnostics, we embrace a culture and mindset that drive our vision and strategy. Our key dimensions include:

Passion for our customers and patients

Radically simplifying processes

Trust, collaboration, and having fun

Leadership at all levels

Continuous experimentation and learning

Join us and be part of a team that makes a difference in the world of diagnostics!

Relocation benefits are not available for this job posting.

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 San Jose provide end-to-end business solutions for Finance, Procurement, IT, Communications, People & Culture (Human Resources) and beyond to our Roche colleagues across the Americas region. Today Roche employs altogether around 800 employees in Costa Rica.

Roche is an Equal Opportunity Employer.