**ROLE SUMMARY** The Country Trials Manager is responsible for study startup deliverables for assigned studies at a country level of limited or moderate complexity. The Country Trials Manager partners with the Study Start Up Project Manager, Study Manager, Site Intelligence Lead, Site Relationship Partner, Site Activation Partner, Contracts Lead, Regulatory Affairs, CRO representatives and others […]
Regulatory Affairs Jobs
**Functiebeschrijving** De Covid **Quality Project (QP) Specialist** zorgt ervoor dat de risico’s en validatie strategie van het COVID project overkoepelend beheerd en gecentraliseerd blijven. In het COVID project kunnen onze standaard procedures voor bepaalde aspecten van het project niet worden gevolgd. Het is de taak van de QP specialist om deze risico’s te beperken en […]
**ROLE SUMMARY** The Country Trials Manager is responsible for study startup deliverables for assigned studies at a country level that are of moderate to high complexity. For studies where there is more than one country trial manager assigned, may act as the Lead Country Trials Manager for the country or cluster of countries and coordinate […]
**ROLE SUMMARY** The Country Trials Manager is responsible for study startup deliverables for assigned studies at a country level of limited or moderate complexity. The Country Trials Manager partners with the Study Start Up Project Manager, Study Manager, Site Intelligence Lead, Site Relationship Partner, Site Activation Partner, Contracts Lead, Regulatory Affairs, CRO representatives and others […]
Role: Senior Regulatory Affairs Specialist Location: Gurugram The Senior Regulatory Affairs Specialist will independently, with minimum supervision, prepare the regulatory submissions and interact with regulatory agencies/health authorities to obtain and maintain product approvals with a focus on India, Bangladesh, Sri Lanka and other international countries, as needed. Work on, Make in India related submissions, ROW […]
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 + Register chemical products for research use per K-REACH regulation and manage labelling requirement in APAC + Register broadcasting & communication equipment for an electrical instrument for research use + Follow Medical Device Act by MFDS and other relevant regulations related to Leica Biosystems products and provide directions for compliance to the organization. […]
**Now’s our time to inspire the future ofhealthcare together.** Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them […]
**Position Summary:** + Role as Site Quality Compliance Team member with primary focus to ensure that the site is in a steady, ready, and prepared state for Inspection Readiness. + Maintain Site Master File and update it when required. + Ensure that GMP standards, as they apply to the individual products and the site, are […]
null **In this role, you have the opportunity to** Provide Regulatory Affairs Support for Advanced Innovation New Product Development and Sustaining efforts in both the domestic and international markets for assigned medical devices and consumer products. Provide direct project support for registration and licensing in the US, Canada and EU and indirect support to the […]
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