Regulatory Affairs Jobs

QA/RA Director

The QA /RA Director serves as the lead Quality Management and Regulatory Affairs representative for Noble International and leads, manages and supports all medical device Quality System and Regulatory activities.

Quality Manager

The Quality Manager is responsible to ensure that the products and services that Noble provides is consistent, meets both external and internal requirements, and coordinates the activities required to meet quality standards. This includes legal compliance and customer expectations.

Regulatory Affairs, Senior Manager

Amgen is seeking a Regulatory Affairs, Senior Manager to work in their Thousand Oaks, CA or Southern San Francisco location. This position will report to Executive Director Regulatory Affairs. The Regulatory Affairs division establishes sustainable processes, assure informed relationships, and deliver strategic outcomes. Develop and implement regulatory strategies and processes for medical devices (eg, drug […]

Regulatory Affairs Companion Diagnostic Lead

Amgen is seeking a Regulatory Affairs, Companion Diagnostic Lead to work in their Thousand Oaks, CA or Southern San Francisco location. This position will report to Director Regulatory Affairs. The Regulatory Affairs lead division establish sustainable processes, assure informed relationships, and deliver strategic outcomes. Develop and implement regulatory strategies and processes for in-vitro diagnostics (IVDs)/companion […]

Global Marketing Sr Mgr, Commercial Business Development Forecasting Lead

The Commercial Business Development Forecasting and Analytics Leader is a key position within Commercial Business Development in Global Marketing. The Sr. Manager will work with the Commercial BD Directors across all therapeutic areas to develop data-driven and insightful commercial analyses in support of external licensing and acquisition opportunities. The Sr. Manager will have two main […]

Quality Assurance Team Lead Submission Quality

**ROLE SUMMARY** The Quality Assurance Team Lead (QA TL) Submission Quality is responsible for defining and executing the audit strategy and operational plan for quality assurance of regulatory submission documents. The QA TL works to ensure that audit quality standards are consistently applied across the submissions portfolio. The QA TL acts as a leader in […]

Sr Quality Operations Specialist

**ROLE SUMMARY** This position is responsible for ensuring that Regulatory, Customer and Corporate commitments, improvement projects and follow up actions are completed and reported within specified timeframes. The Sr. QO Specialist – Compliance is also responsible for supporting preparation of regulatory/customer/corporate responses, follow up reports, preparing responses to customer requests for information, such as product […]

Medical Advisor

POSITION RESPONSIBILITIES In order of importance, list the key accountabilities critical to the performance of the position. It is recommended not to list actual tasks but focus on essential responsibilities that highlight accountability and level of judgment required. • Maintain high-level medical expertise for responsible therapeutic areas, Pfizer products and portfolio • Develop and execute […]

Application Specialist

**Danaher Company Description** Leica Biosystems is a global leader in workflow solutions and automation. As the only company to own the workflow from biopsy to diagnosis, we are uniquely positioned to break down the barriers between each of these steps. Our mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate […]

Director of Quality-Transcatheter Mitral Valve Replacement (TMVR)

Director of Quality-Transcatheter Mitral Valve Replacement (TMVR) Location: Santa Rosa, California, United States Requisition #: 18000G4V Post Date: 2 days ago CAREERS THAT CHANGE LIVES: Apply multidisciplinary knowledge to design, develop direct the quality assurance function at the CSH TMVR business. Manage Quality team in multiple locations including Santa Ana, CA, Redwood City, CA, Santa […]

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