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Are you a fix-it person? Do you have significant medical device experience? We have a medical device Quality Improvement project expected to last 9 months in Orange County. The project is to improve operations process and manufacturing. A team of engineers is to be deployed to uncover and eliminate root causes for product defects. These are temporary positions paid on a W-2 through our staffing firm. QualificationsBS in Engineering or Health SciencesExperience with FDA and/or International....

- Irvine, CA

This is a temp-to-hire situation expected to last 6 months. Qualifications - B.S. degree. - Minimum of 3 to 5 years of pharmaceuticals/biotech experience. - Minimum of 3 to 5 years drug development experience in the pharmaceutical industry/CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials Duties - Supports the Sr. CTM/operational study lead in collaborating with clinical affairs and other functions, and responsible for, the execution and....


Large Pharma client needs a temp-to-hire for execute study site startups. Required Qualifications & Experience: Bachelor’s in life sciences or related field At least 2 years experience in clinical research Prefer candidate with prior experience as Study Start-Up Specialist but not mandatory. Site Regulatory Documents Collection (FDA Form 1572, Signature Pages, Medical Licenses, etc.) Review of Informed Consent Form(s) in order to obtain IRB approval (interface with Legal, Medical Safety....

- 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....


In need of a part-time HR manager for two days a week with a food manufacturing company in Orange, CA. This position reports directly to the owner of the company. Required Qualifications:Experience managing systems for seasonal workforceAssociates Degree or higherDesired Qualifications:Experience selecting HR softwareExperience setting up HR systems such as onboarding, offboarding.

- Dongyang, Zhejiang, China

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.


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....

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