Regulatory Affairs Jobs

Senior Design Quality Engineer

null **In this role, you have the opportunity to** You are the main interface between the QA team and development team. You facilitate meeting project goals in a compliant manner and you understand how quality policies and development processes interact. You work closely with Regulatory Affairs, Product Development, Clinical, Operations, Service, Supply Chain and Marketing […]

Regulatory Affairs Expert

**Danaher Company Description** HemoCue, acquired by Radiometer Medical ApS in April 2013, is a global leader in point-of-care testing. HemoCue AB (Ängelholm, Sweden), introduced in 1982 the first accurate, near-patient hemoglobin test. The company also sells point-of-care tests for glucose, urine albumin, HbA1c, total and differential white blood cell count. Further information, Radiometer – […]

Product Compliance Specialist

**Danaher Company Description** *Hach*is a world leader in the manufacture and distribution of analytical instruments, test kits and reagents for testing the quality of water, aqueous solutions and air. Our products are designed specifically for quality, accuracy, and simplicity. Strengthened by our sister companies in the environmental industry worldwide, our goal for the future is […]

Senior Director Commercial Quality and Regulatory Affairs

**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 […]

Regulatory Affairs Specialist III

**Danaher Company Description** At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert® System, we’ve taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing […]

Quality and Regulatory Affairs Manager Iberia

At Cardinal Health, we’re developing the innovative products and services that make healthcare safer and more productive. Join a growing, global company genuinely committed to making a difference for our customers and communities. Regulatory Affairs Manufacturing (FDA) is responsible for planning, coordinating and implementing regulatory strategies for products that require government approval. We are currently […]

Regulatory Associate

The Regulatory Affairs Associate is mainly responsible for regulatory affairs support related to lifecycle management within the country including renewal. The activities encompass regulatory submissions to the authorities for registration of variations to marketed products, and miscellaneous application such as ad-hoc requests and permits, special exemption when required, and general product maintenance. Pfizer is an […]

Labeling Artwork & Packaging Implementation Specialist

**JOB SUMMARY** Colleague fundamentally performs the ePALMS system ” Market Coordinator ” role in close collaboration with the Global Regulatory Affairs (GRA) Strategy functions at Pfizer Country Offices (PCOs) and is the central Regulatory point of contact for the PGS plants/Artwork Centers (AWC). Colleague operates from a subject matter expert (SME) centralized “hub” capacity and […]

Manufacturing Quality Engineer (BV) – 12 month FTC

**Danaher Company Description** Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems, found in hospitals and other critical care settings around the world, produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study […]

Regulatory Affairs Operations Manager

Regulatory Affairs Operations Manager Location: North Haven, Connecticut, United States Requisition #: 190000A7 Post Date: Jan 30, 2019 **REGULATORY AFFAIRS OPERATIONS MANAGER** **SURGICAL INNOVATIONS** set the standard for Minimally Invasive Surgery (MIS) by creating innovative surgical products and services that focus on obesity and diseases and conditions of the gastrointestinal tract, lung, abdominal wall, pelvic […]

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