Regulatory Affairs Specialist - Contractor - Temporary
Company: Hoffmann-La Roche Ltd
Posted on: June 12, 2021
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
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
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
May assist in review of labeling changes, as well as advertising
and promotional materials.
May assist as the internal regulatory consultant for on-market
- May assist in review of proposed device changes.
Bachelor's Degree in a science, engineering, or related
2 years of experience in a FDA regulated industry, or equivalent
Experience working in a cross-functional team setting is
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
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
Keywords: Hoffmann-La Roche Ltd, Tucson , Regulatory Affairs Specialist - Contractor - Temporary, Other , Tucson, Arizona
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