Provides skilled regulatory and administrative support to the Regulatory Affairs staff. Responds to internal and external requests for regulatory information.
Principal Duties and Responsibilities
Coordinates support activities for CE marking, technical filing papers, dossier dispatch schedule, standards tracking and various regulatory labeling processes
Provides clerical support needed to obtain regulatory approval for Zimmer Biomet products
Utililizes several different computer sources for maintaining and extracting data.
Assist other staff as needed
General typing and filing of RA documents
Miscellaneous responsibilities as assigned
Interact in a diverse environment, working with individuals in different geographies and countries
Receives and handles field requests for information on the regulatory status of Zimmer Biomet products
May train and mentor RA Coordinators as needed
Expected Areas of Competence
•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 skills, both written and oral
•Ability to work with individuals at all levels of the organization as well as government agencies, healthcare personnel and sales associates
•Self-motivated; ability to work with minimal supervision
•Ability to follow instructions, take direction from multiple sources, and balance changing priorities
•Strong attention to detail; produces high quality work without errors; able to detect spelling, punctuation and proofreading errors
•Ability to handle and direct urgent inquiries (e.g. calls from FDA or hospital personnel) in a professional manner
•Proficiency in Windows applications, Office Suite, and database applications
•Ability to type 40-50 wpm with 95% accuracy
•Ability to train others to perform job tasks
•H.S. diploma or equivalent, required.
•A minimum of 4 years in an RA Coordinator position or similar role, required
•Familiarity with medical terminology, anatomy and product knowledge, strongly preferred
•A combination of education and experience may be considered.
Up to 5%