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Compliance Specialist

Nesco Resource

This is a Full-time position in Tucson, AZ posted June 8, 2021.

Nesco Resource is looking to hire a Regulatory Affairs Specialist on a contract position in Tucson AZ

 

POSITION SUMMARY: This Regulatory Affairs Specialist with be responsible for activities which lead to and maintain domestic and international regulatory approval to market devices, as well as the assessment of device changes for regulatory implications.

 

ESSENTIAL FUNCTIONS:

– 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 and provide regulatory support on project teams.

– May assist in the creation of Operating Procedures and policy guidelines and the review of labeling changes, as well as advertising and promotional materials.

– May assist as the internal regulatory consultant for on-market product issues, as well as review of proposed device changes.

 

MINIMUM QUALIFICATIONS:

Formal Training/Education: – B.S./B.A. in a science, engineering, or related technical field.

Experience:

– 2 years experience in a FDA regulated industry, or equivalent is preferred.

– Experience working in a cross-functional team setting is preferred.

– Medical Writing experience is preferred.

 

If Interested, Apply Now or Call Kati at 520-319-1011.