POSITION: Regulatory Specialist

JOB DUTIES: To Author regulatory submissions for submission to US FDA, Prepare eCopy and package for FDA regulatory submissions, Review complete submissions for consistency with current FDA standards, Coordinate regulatory documentation activities and establish organizational guidelines or policies, Act as liaison with governmental agencies and medical device manufacturers, Gain familiarity with FDA regulations guidance documents and stay up- to-date with new regulations, Organize documentation to ensure traceability, maintain archives, Business development, interface with clients to clarify and market consulting services. 

REQUIREMENTS: Master’s Degree and 6 Months of Experience in Position Required by AcKnowledge Regulatory Strategies, LLC. 

WAGE: Wage of $64,085.00/year will be paid

LOCATION OF EMPLOYMENT: 2834 Hawthorn Street, San Diego, CA, 92104

SEND RESUME TO: Allison C. Komiyama, PhD, RAC

TELEPHONE: 619-738-8646