Job Information
Envista Holdings Corporation RA Referent in Modi’in-Maccabim-Re’ut, Israel
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.
Envista is a global family of more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. Envista companies, including DEXIS, Kerr, Nobel Biocare and Ormco, partner with dental professionals to help them deliver the best possible patient care.
Envista became an independent company in 2019. We brought with us the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus to meet the end-to-end needs of dental professionals worldwide. Envista is now one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry. For more information, please visit www.envistaco.com .