HI , I hope you are doing good,
*Job Title: Regulatory Affairs Specialist* *Location: Santa Clara, CA * *Duration: Long Term Contract* *Job Description* • Prepares robust regulatory applications supporting International geographies to achieve departmental and organizational objectives. Supports EU MDR transition activities and maintains product technical files. • Creates, reviews and approves engineering change order and prepare worldwide Regulatory assessments • May act or assist as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team. Provides guidance and expertise. • May act or assist as liaison between the Company and the various appropriate regulatory agencies, ensuring that communications on both sides are germane, specific and convey all necessary detail. • Maintains ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel. • Reviews device labeling and marketing materials for compliance with submissions and applicable regulations. • Supports the product release process by completing requests for product release. • Conducts reviews of product and manufacturing changes for compliance with applicable regulations. • Reviews protocols and reports to support regulatory submissions. • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. • Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. • Performs other related Regulatory Affairs duties and responsibilities, as assigned. *General Qualifications* • BA or BS degree (degree in a technical discipline highly preferred). • A minimum of 5 years of technical experience, ideally having at least 2 years of direct regulatory experience in the medical device industry. • Working knowledge of US FDA and International Regulation of medical devices • Experience with international submissions and notification processes, EU design dossier submissions, and US submissions (510(k) applications, PMA supplements). • Experience working in a broader enterprise/cross-division business unit model preferred. • Ability to work in a highly matrixed and geographically diverse business environment. • Ability to work within a team and as an individual contributor in a fast-paced, changing environment. • Ability to leverage and/or engage others to accomplish projects. • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. • Multitasks, prioritizes and meets deadlines in timely manner. • Strong organizational and follow-up skills, as well as attention to detail. • Ability to maintain regular and predictable attendance. Thanks & Regards, Sai Kiran Nandrolu Sr. Recruiter E: saikiran.nandr...@w3global.com A: 1701 Legacy Dr, Suite#1000, Frisco, Texas - 75034 -- Are you =EXP(E:RT) or =NOT(EXP(E:RT)) in Excel? And do you wanna be? It’s =TIME(2,DO:IT,N:OW) ! Join official Facebook page of this forum @ https://www.facebook.com/discussexcel FORUM RULES 1) Use concise, accurate thread titles. Poor thread titles, like Please Help, Urgent, Need Help, Formula Problem, Code Problem, and Need Advice will not get quick attention or may not be answered. 2) Don't post a question in the thread of another member. 3) Don't post questions regarding breaking or bypassing any security measure. 4) Acknowledge the responses you receive, good or bad. 5) Jobs posting is not allowed. 6) Sharing copyrighted material and their links is not allowed. NOTE : Don't ever post confidential data in a workbook. Forum owners and members are not responsible for any loss. --- You received this message because you are subscribed to the Google Groups "MS EXCEL AND VBA MACROS" group. To unsubscribe from this group and stop receiving emails from it, send an email to excel-macros+unsubscr...@googlegroups.com. To view this discussion on the web visit https://groups.google.com/d/msgid/excel-macros/CAGquW%2B%2Bb%3Du1-45SSLUA3xEzkGY4OHLm6%3D_SJ89cRBnrSqMLf_g%40mail.gmail.com.
