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Auditor needed for an Active Pharmaceutical Ingredient (API) qualification audit for a prospective contract manufacturer located in Zhejiang, China. The auditor needs some familiarity with spoken Mandarin. Certified Quality Auditor (CQA) preferred. Audit is proposed for December 13-15, 2017. For more information visit https://meirxrs.com/gmp-auditors/


Clinical Research Coordinator needed for Alzheimer's studies. Entry Level and career transitions OK, employer is willing to train but candidate must have completed CITI Good Clinical Practice (GCP) and HIPS prior to starting. Associates degree or higher degree required, preferably in healthcare or life sciences. Download our white paper to understand how clinical research sites work. Responsibilities:Complete and ensure the quality of case report formsConducting study visits, including vital....


Sr. Regulatory Affairs Specialist Irvine, CA Essential Duties and Responsibilities:Regulatory requirement support for product registrations and distribution for both domestic and international regulatory agenciesEnsure internal documents and agency filings are in compliance with applicable regulations and company Standard Operating Procedures (SOPs)Regulatory review of labeling, advertising, and document change ordersAdverse Event and Medical Device Reporting (MDR)Product and labeling update....

- Any US State

Our client needs a doctor with experience in oncology clinical drug development to serve as a medical monitor. Work is estimated to take 10 hours per week to start.RequirementsMedical Doctorate (MD) or equivalent5 years clinical drug development experience in oncologyPhase 1 and phase 2 studiesResponsibilities1. Available to clinical investigator sites as a go-to person in the US for checking eligibility2. Be responsible for interacting with sites on safety management of the study. This will....


Are you looking for a rare, ground floor opportunity to join a dynamic, rapidly growing, privately owned company? Our client has an immediate need for a Vice President of Genomic Research. Reporting directly to the CEO, the VP will lead the Genomics Research group. The ideal candidate will:Have experience leading development and validation of a multiplex genomic testBring a strong background in immunology, blood based genomics, and computational biologyDirect and ensure execution of studies....

- Boston/San Diego/Minn, AL

Roles and Responsibilities: Assessment of non-active medical devices and their manufacturers per the European Medical Devices Directives, other applicable Regulatory Systems and International standards, including related client and project management75% auditPerform regulatory audits of clients per European Medical Device Directives (AIMD, MDD, IVDD), Canadian Medical Device Regulations (CMDR), Japanese Pharmaceutical Affairs Law (JPAL) and International quality system standards (e.g. ISO....

- San Diego/Home, CA

(Home Based – Offices in San Diego, CA) Roles and Responsibilities: Assessment of active and non-active medical devices and their manufacturers per the European Medical Devices Directives, other applicable Regulatory Systems and International standards, including related client and project management Perform conformity assessments of regulatory submissions to relevant safety principles and standard requirements:Design DossiersTechnical DocumentationsPerform regulatory audits of clients per....

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