Coordinator, Regulatory Affairs

Job Summary –Responsible for assisting Regulatory Affairs personnel and independently research regulatory files and databases to respond to requests from inside and outside Zimmer. General Functions –§ Coordinates support activities for CE marking, technical filing papers, dossier dispatch schedule, standards tracking and various regulatory labeling process.§ Provides clerical support needed to obtain regulatory approval for Zimmer products.§ Utililizes several different computer sources for maintaining and e3xtracting data.§ Assist other staff as needed.§ General typing, filing of Regulatory Affairs documents.This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions".Expected Areas of Competence (i.e. KSAs) –§ Possess previous office experience with proven ability to manage, organize and prioritize all the detailed aspects of several projects simultaneously.§ Ability to deal with difficult situations with tact and professionalism.§ Excellent communication, both oral and written, and ability to work with employees at all levels of the organization.§ Be self-motivated while working in an isolated office area with minimal supervision.§ Able to follow instructions, and take direction from multiple sources with changing priorities.§ Must be detail oriented and possess ability to file/retrieve data and to assemble submissions in a quality manner.§ Ability to handle and direct telephone calls in emergency situations, i.e., calls from FDA or hospital personnel must be dealt with professionally and with urgency.§ Ability to interact with Zimmer management, government agencies, health care personnel and sales associates.§ Ability to lean key activities related to the position.Education Requirements – High school diploma or equivalent is required.Skill Requirements – PC literate and demonstrate proficiency in Windows, word processing software, (Word, WordPerfect), and database applications (File Express, Sybase). Ability to type 40-50 wpm with 95% accuracy. Secretarial skills with ability to detect spelling, punctuation and proofreading errors. Familiarity with medical terminology, anatomy, and product knowledge.Education: High School Diploma / GEDJob Level: 1 - 2 yearsPercent Travel: No Travel