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About our client
Our client is located in Kirkland Lake, Washington, and was founded in late ’80s. The company is into designing, developing and manufacturing innovative medical devices intended for the treatment of arterial disease. The company's primary focus is on peripheral artery disease (PAD).
Position	Location
Director of Regulatory Affairs	Washington
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Oversee and manage the activities of the regulatory affairs department 2) Ensure the development and implementation of strategies for all regulatory approvals 3) Ensure timely preparation of organized and valid submissions 4) Develop and maintain robust regulatory processes 5) Provide expertise in translating regulatory requirements into practical, workable plans for the organization
Requirements
1) Bachelor’s degree 2) Advanced degree preferred 3) Minimum of 8-10 years of experience in regulatory affairs in the medical device industry 4) Knowledge and experience applying premarket approval/product registration requirements (IDEs, 510ks, PMAs, etc.) 5) Supervisory/management experience or demonstrated ability to lead cross-functional, cross-business teams 6) Knowledge and experience applying adverse event reporting laws, regulations, guidance and policies 7) Demonstrated experience working with regulatory agencies such as the FDA