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Regulatory Affairs Specialist - Contractor - Temporary

Company: Hoffmann-La Roche Ltd
Location: Tucson
Posted on: June 12, 2021

Job Description:

Three positions available.

Responsible for activities which lead to and maintain domestic and international regulatory approval to market devices. Responsible for assessment of device changes for regulatory implications.

Responsibilities:

  • 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.

Qualifications:

  • Bachelor's Degree in a science, engineering, or related technical field

  • 2 years of experience in a FDA regulated industry, or equivalent is preferred

  • Experience working in a cross-functional team setting is preferred

  • Strong organizational skills and attention to detail

  • Experience with Microsoft based applications and general knowledge of PC functions

  • Ability to work in a fast-paced/entrepreneurial team environment

  • Results and goal oriented

  • High degree of initiative with the ability to work independently with some supervision

  • Excellent oral and written communication skills

  • Ability to prepare and present information to groups

  • Ability to plan and organize work while remaining flexible

  • Excellent time management skills

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

If you have a disability and need an accommodation in connection with the on-line application process, please email us at US.Accommodation@roche.com.

Keywords: Hoffmann-La Roche Ltd, Tucson , Regulatory Affairs Specialist - Contractor - Temporary, Other , Tucson, Arizona

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