Project Manager - Regulatory

REGULATORY AFFAIRS PROJECT MANAGERSummary:

 

Profitable Medical Device Company in Irvine is seeking an experienced Project Manager of Regulatory Affairs.   Qualified candidates will be responsible for the development, retrieval and maintenance of worldwide Regulatory Submissions, licenses, and certificates.  Company is currently in a number of different phases of their clinical trials, potential candidates need to be experienced in all phases.   The Project Manager will generate development plans/ documents and oversee/finalize submissions within timelines. Responsibility includes the review of product changes and their impact upon regulatory submissions and licensing.  Leads the effort to support design teams and provide submission requirements for gaining marketing approvals in the US and worldwide. Supports Design Controls and provides documentation for Design History Files.  Position will report directly to the VP of Clinical Affairs. 

 

 

Background Qualifications:

 

BA/BS degree with a minimum of 5-7 years Regulatory Affairs experience.

Experience in successful completion of writing and submitting US product marketing approvals (510(k)/IDE/PMA) and OUS product marketing approvals (CE Mark, Canada, Asia)

Expert in US FDA regulations for gaining medical device approvals/exporting medical devices/clinical studies.

Understands ISO 13485:2003, MDD, Canadian CMDR, and QSR requirements.

Proven analytical and problem solving skills.

Self-initiator in relation to project and/or project teams and can work under aggressive timelines.

Excellent verbal and technical writing communication skills.

Excellent computer skills.

Ability to travel up to 25%.