Help us improve access to life-changing therapies that can transform human health We are Cytiva, a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. Formerly part of GE Healthcare, we have a rich heritage, and a fresh beginning since 2020. Our customers undertake life-saving activities. These range […]
Regulatory Affairs Jobs
**Are you looking for a career that matters?** We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with […]
null #LI-MK3 **Regulatory Affairs Specialist** **Organization Description:** Clinical Care Informatics is a dynamic business that provides Philips Healthcare customers with Electronic Medical Record and Analytics solutions. The position will be part of the Quality and Regulatory organization. **Your Responsibilities:** As a core member of multiple new product development teams, the Regulatory Specialist will provide timely […]
null **In this role, you have the opportunity to** Review and ensure Philips quality systems, behaviors, and performance meet all requirements (regulatory, applicable standards, and internal). This position looks globally across all Philips operations, and engages in Quality Management System audits, Good Clinical Practice audits, Mergers & Acquisition activities, and other initiatives as available. **You […]
null **In this role, you have the opportunity to** Manage a talented Software Development and Test team that collaborates closely with other Engineers, Clinical Specialists, Product Marketing, Operations, Quality and Regulatory Affairs in the Ventilation business within Hospital and Respiratory Care (HRC) to develop and commercialize Class 2 medical devices. **Responsibilities** + Lead and Manage […]
Position Summary To lead projects relevant to Regulatory Affairs (Registration, Regulatory strategy, etc.) on time. 2) To lead In Vitro Diagnostics (IVD) and Medical Device (MD) registration and discuss with Japanese regulatory agencies. 3) To lead clinical trial for IVD registration and discuss with clinical site or commercial laboratory. 4) To lead documentation and administration […]
null **Venha fazer parte da nossa missão de melhorar a vida de milhões de pessoas! ** Estamos à procura de profissionais que gostem do desafio de trabalhar comum produto fortemente regulamentado, com alto nível de senso de urgência, flexibilidade, mudança de prioridades conforme as necessidades e com um forte espírito de equipe. **Você fará parte […]
This is a professional position with responsibilities for elements of the site regulatory obligations. May include specialized responsibilities in identification and implementation via the regulatory intelligence process of new or revised guidance and regulations, specifically IVDR; communications with regulatory bodies; regulatory compliance assessments, post-market surveillance; regulatory core team member for new product development and device […]
The Regulatory, Quality & Clinical Affairs Specialist will assist in the compliance of LMS with applicable governmental regulatory policies and procedures as well as applicable corporate and divisional policies and procedures. You will be expected to maintain current knoweldge of FDA, Health Canada, and European regulations, legislation, best practices, and guidelines related to RA/QA. Assist […]
POSITION SUMMARY: The Legal and Compliance Counsel will be responsible for providing guidance, direction and assistance primarily to Cepheid, but also as shared resources to other Danaher Dx companies, in connection with a wide variety of (a) legal and business matters and (b) for supporting the Compliance Program, to support Commercial, High-Burden Developing Countries (HBDC) […]
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