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Regulatory Affairs Specialist I

Company: Ascent
Location: Tucson
Posted on: November 22, 2021

Job Description:

General Information:Req# Job Title Regulatory Affairs Specialist IDepartment Regulatory AffairsJob Category Quality and RegulatoryType: Initial 12-36 month contract opportunity -will be a W2 employee of Ascent/Client working onsite at our infamous client in TucsonLocation:Tucson, AZPay Range: $25 - $30/hr Client info:an amazing opportunity for someone who is interested in pursuing a career within Regulatory within Cancer Research, Biochemistry and Biomedical Devices!This client highly values and invests in Research and Development. Being the market leader in Tissue Diagnostics, this company can dictate the technology and new product pipeline in the industry.Duties: - Assist in activities associated with regulatory approval of in vitro diagnostic medical devices in global markets.- Assist in submission activities for a variety of device regulatory approvals including the CE mark, US premarket approvals (PMAs), US premarket notifications (510(k)s), post-approval reports, export certificates, establishment registrations and listings, etc.- Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and discipline as relevant to assigned projects.- May interface with regulatory authorities on regulatory and technical matters, as directed.- May provide regulatory support on project teams.- May assist in the creation of Operating Procedures and policy guidelines.- May assist in review of labeling changes, as well as advertising and promotional materials.- May assist as the internal regulatory consultant for on-market product issues.- May assist in review of proposed device changes.Softskills needed: - Ability to prepare and present information to groups.- Ability to plan and organize work while remaining flexible.- Excellent time management skills.- Strong organizational skills and attention to detail required.- Ability to work in a fast-paced/entrepreneurial team environment.- Results and goal oriented.- Excellent oral and written communication skills.- High degree of initiative with the ability to work independently with some supervision.- Experience working in a cross-functional team setting is preferred.Requirements: - Experience with Microsoft based applications and general knowledge of PC functions necessary.- 2 years experience in a FDA regulated industry, or equivalent is STRONGLY preferred.-Education: - B.S./B.A. in a science, engineering, or related technical field.COVID UPDATE: Beginning November 15, 2021, End Client requires all US based new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at End Client , an d it applies regardless of whether the position is located at a End Client campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request accommodation.

Keywords: Ascent, Tucson , Regulatory Affairs Specialist I, Other , Tucson, Arizona

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