Experis, a ManpowerGroup company, has an exciting contract opportunity with one of our key clients, an American supplier of scientific instrumentation, reagents and consumables, and software services with a mission to enable the customers to make the world healthier, cleaner and safer.
Regulatory Affairs Specialist II
Location: West Hills CA
Duration: 12 months
* Develop and write clear processes for regulatory approvals Prepare submissions of license variations and renewals.
* Monitor and set timelines for license variations and renewal approvals.
* Work with R&D teams to plan and develop strategy for design control and regulatory market access.
* Advise scientists and manufacturing teams on regulatory requirements.
* Liaise with and participate in the interactions and negotiations with the FDA, Authorized Representatives, Competent Authorities, Notified Bodies and other regulatory agencies to achieve regulatory approval.
* Develop strategies to obtain appropriate regulatory clearances and assess the type and amount of product performance data required to ensure product approval.
* Work on extremely complex problems where analysis of situations or data requires an evaluation of intangible, variable factors.
* Provide leadership for the regulatory function and coordinate activities directed toward obtaining marketing clearance for all diagnostic products.
* Bachelor's degree required, with advanced degree preferred
* Minimum of 2-5 years of Regulatory Affairs
* Diagnostics industry experience is preferred.
- Diagnostic Skills
- Regulatory Requirements