Regulatory Affairs Specialist Senior
Posted on: June 16, 2019
As a Regulatory Affairs Specialist, Senior, you will support
submissions in the US and ex-US. In addition, you will participate
on project teams with internal and external partners. Aid in the
management and completion of annual reporting of product and
process changes, clinical trial applications, and other periodic
- Assist in activities associated with regulatory approval of in
vitro diagnostic medical devices in global markets.
- Provide support to currently marketed products, e.g., review
engineering changes, labeling, promotional material, product
changes and documentation for compliance and for changes requiring
regulatory agency approval, as pertains to US and international
- Responsible for maintenance of product technical files and for
ongoing activities related to compliance with global directives and
- 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.
- Interface with regulatory authorities on regulatory and
technical matters, as directed.
- May provide regulatory support on project teams.
- Assist in the creation of Operating Procedures and policy
- Assist in review of labeling changes, advertising and
promotional activities, etc.
- May assist as the internal regulatory consultant for on-market
- Assist in review of proposed device changes.
- May perform other duties as required or assigned.
- B.S./B.A. in a science, engineering, or related technical
field; advanced degree preferred. Regulatory Affairs Certification
- 3 years experience in regulatory, development, clinical
affairs, quality, or program management in IVD, medical device, or
pharma industries. Regulatory affairs experience is preferred. IVD
device experience is preferred.
- Experience with regulatory submissions including IDE, 510(k),
and PMA submissions is preferred.
- Experience working in a cross-functional team setting is
Roche is an equal opportunity employer.Regulatory Affairs,
Regulatory Affairs > General Regulatory Affairs
Keywords: Roche, Tucson , Regulatory Affairs Specialist Senior, Other , Tucson, Arizona
Didn't find what you're looking for? Search again!