RA Referent

Operating Company: Implant Direct
Location: Modi'in-Maccabim-Re'ut,HaMerkaz (Central),IL
Date Posted: June 20, 2024
Req Number: R5019982
Job Description: Responsible for RA activities: submission of new projects, maintenance of current certificates, AMARs, Periodic submissions, One Time submissions. Submission of AMARs for OpCos in Israel. Communication with competent authorities in Israel, relevant RA persons in OpCos Operating Priority system, handle of POs. Preparations of samples for submission purpose. Preparation of ECO of Labeling: labels, IFUs, translations. Support in RA projects following business needs in Israel and LATAM counties. Contact with internal and external interfaces. Reading and writing technical documents in English Job Requirements: Critical Knowledge and Qualifications: High level of English in writing and understanding of technical documents, excellent organized with documentation – order, good communication skills, Accurate work with documentation. Communication skills – knowledge of the best practices and how own area integrates with others (QA, R&D Product Management, Marketing etc.). Capable of leading small projects with manageable risks and resource requirements. Critical Skills/technical know-how: Engineering skills for RA purpose: understanding of drawings, specifications, etc. Preparation of technical specifications using template. Critical Experience: English, technical approach, experience of working with documentation. Working independently a minimum of one year of experience as a regulatory Affairs or registration assistant in a medical devices company Operating Company: Implant Direct Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.