Medical Device Regulatory Affairs Associate-Temp-Perm-Sorrento Valley

Kelly Scientific Resources, a global staffing leader, is currently seeking a Regulatory Affairs Associate in the Sorrento Valley area of San Diego, CA.This position will be responsible for:'Coordinates submission and review of documents for inclusion in Design History files.'Drafts, edits and compiles technical files and design dossier in support of EU regulatory filings. 'Prepare regulatory submissions (FDA 510(k)s, Technical files for CE documents for Canada Device License Applications. 'Registration/Application of Class II & III Medical Devices Licenses in Health Canada.'Research FDA, CMDR, MDD & IVDD guidance documents for regulatory requirements. 'Prepare clinical study protocols and required documentation for IRB approval.'Act as Regulatory Affairs liaison for clinical research groups and company personnel.'Coordinates all aspects of the clinical study process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices.'Verify and analyze clinical study data to ensure accuracy, validity and reliability.'Review and approve labeling, package inserts, ad materials and company website to meet the FDA regulatory requirements.'Maintain Essential Requirements Checklists, ensuring that applicable standards are utilized and updated as revisions are introduced.The qualified candidate will have a Bachelor's degree in a Life Science, 2+ years of direct Regulatory experience, strong writing skills, excellent communication skills (both written and verbal), expert knowledge of QSR's, GCP regulations, good documentation practices, computers and software programs, high attention to detail and the ability to manage a large amount of projects with a variety of deadlines at any given time.The qualified candidate will also exude specific traits including independence, self-motivated, excellent interpersonal skills and listening skills, patience and resolve, drive to go above and beyond, organized and meticulous, and strong multi-tasking abilities.This is a temp-perm position located in San Diego, CA and is an urgent need. The salary range for this position is $45-60K/year DOE.Click on the 'Apply Now' link below to submit your resume to this position. Learn more about company