Regulatory Specialist Diagnostics (Temporary, Fixed-Term) job opportunity at Roche.

Home Jobs In Costa Rica Tag: Fixed-Term) Regulatory Specialist Diagnostics (Temporary, Fixed-Term) position at Roche


DatePosted 5 Days Ago bot
Roche Regulatory Specialist Diagnostics (Temporary, Fixed-Term)
Experience: 5-years
Pattern: full-time
Country:
apply Apply Now
Salary:
Status:

Fixed-Term)

Copy Link Report
degreeOND
loacation San Jose, Costa Rica, Costa Rica
loacation San Jose, Cost..........Costa Rica

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.

Other Ai Matches

Alternant - Ventes à Distance en Biologie Moléculaire (f/m/d) Applicants are expected to have a solid experience in handling Job related tasks
Disease Area Squad Lead Hemophilia Applicants are expected to have a solid experience in handling Job related tasks
Regulatory Affairs Specialist Applicants are expected to have a solid experience in handling Job related tasks
HR Business Partner (Advisory) - Portuguese Applicants are expected to have a solid experience in handling Job related tasks
Travel & Expense Compliance Intern Applicants are expected to have a solid experience in handling Job related tasks
Specjalista/-ka ds. Serwisu Technicznego (Service Engineer) Applicants are expected to have a solid experience in handling Job related tasks
Alternant - Marketing Omnicanal (f/m/d)  Applicants are expected to have a solid experience in handling Job related tasks
Quality Assurance Manager Qualified Person Applicants are expected to have a solid experience in handling Job related tasks
AI & Data Science Intern Applicants are expected to have a solid experience in handling Job related tasks
Business Analysis Manager (Manufacturing IT System) Applicants are expected to have a solid experience in handling Job related tasks
Sr Manufacturing Engineer - Controls Applicants are expected to have a solid experience in handling Job related tasks
Account Executive - Molecular Diagnostics - AL, MS, Pensacola Applicants are expected to have a solid experience in handling MS, Pensacola related tasks
Patient Journey Partner, Quebec Applicants are expected to have a solid experience in handling Quebec related tasks
Intern - Marketing Applicants are expected to have a solid experience in handling Job related tasks
Internship in the field of bioconjugation (m/f/d) Applicants are expected to have a solid experience in handling Job related tasks
Network Service Delivery Lead Applicants are expected to have a solid experience in handling Job related tasks
ITOT Engineer Intern Applicants are expected to have a solid experience in handling Job related tasks
Engineer Post - Market Quality (PMQ) Applicants are expected to have a solid experience in handling Job related tasks
Teamlead Filling & Lyo Large Scale 2 (m/w/d) Applicants are expected to have a solid experience in handling Job related tasks
Patient Journey Partner Applicants are expected to have a solid experience in handling Job related tasks
Cost Accounting SME (ASPIRE project: S/4Hana Implementation) - Fixed term Applicants are expected to have a solid experience in handling Job related tasks
Expert, Manufacturing OE& BPM 专家, 生产精益运营与业务流程管理 Applicants are expected to have a solid experience in handling Manufacturing OE& BPM 专家, 生产精益运营与业务流程管理 related tasks
Section Lead Process Science and Data Flow Applicants are expected to have a solid experience in handling Job related tasks