Regulatory Specialist Diagnostics

hace 1 semana

Sabana Norte San Jose, Costa Rica Roche A tiempo completo

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

**This is a temporary, fixed term position through 12/31/2026

The Opportunity:
As a
Regulatory Specialist**
, your main responsibility is to support planned product registration timelines and maintain product registration throughout its lifecycle. You will ensure successful regulatory change control and maintain clear agreements with stakeholders like health authorities.

Key Responsibilities:

  • Documentation and Maintenance: Compile regulatory documents , maintain product registration , and ensure regulatory change control is applied
  • Compliance and Reporting: Provide support for currently marketed products, including labeling and manufacturing changes for compliance, and handle annual/laser reporting
  • Data and Systems: Interface with internal stakeholders to collect data , prepare and maintain regulatory documentation , and manage the Regulatory Information Management System (RIMS) (documentation, product info, and reports)
  • Submissions: Support documentation management workflows and appropriate submission activities (e.g., PMA supplements, 510(k), SRD, IDE memos)
  • International Support: Provide data/documents for international submissions and answer Health Authority questions

Who you are:

  • Education/Experience: Bachelor's/Master's degrees or equivalent experience. 1-5 years of 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
  • Language: Fluent in English and Spanish
  • Skills: Proven ability to work independently
  • Knowledge: Familiarity with global regulatory requirements, guidelines, and procedures for In Vitro Diagnostic or Medical Device instruments & software preferred

Relocation benefits are not available for this job posting
Who we are

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.

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