The Manager of Regulatory Affairs leads and coordinates the process of local and international regulatory submissions and maintaining of current company certifications, along with reviewing, coordinating and maintaining of company controlled documents (PLM SW) in accordance with all applicable international and local regulatory requirements.
· Aid and participation in preparing and writing of IDE’s, PMA Amendments, Annual reports, Pre-Sub documents, annual Registration and Listing and othersubmissions to US FDA.
· Preparation and maintenance of CE Technical Documentation and other required documents for EU Notified Body and/or EU Competent Authorities.
· Assuring compliance with applicable regulatory requirements for European Authorized Representative (EAR) in the framework of CE Mark of company products.
· Preparation and management of regulatory submissions to regulatory authorities worldwide, including Israeli MOH, according to company priorities.
· Assuring Device Labeling is compliant with applicable regulatory requirements for the intended target market.
· Aid in preparation for and participation in audits/inspections by regulatory bodies.
· Reviewing and proofreading of documentation including, but not limited to the following subjects: Quality System documentation, DMR SOPs, regulatory submissions’ documents.
Skills and abilities (required for the job)
· Good knowledge and experience in ISO 13485, 21 CFR Part 820, 93/42/EEC Directive
· Ability to draft and prepare regulatory submissions and updates to CE NB, FDA, Health Canada and MOH Israel.
· Excellent communication and writing skills – English at the level of mother tongue (speak, read, and write) and Hebrew at high level (speak, read, write)
· Detail oriented
· Ability to handle multiple tasks simultaneously
· A team player
Education, experience and training (required for the job)
· Bachelor or Master’s degree in a scientific or engineering discipline or practical experience of at least 4 years in medical device companies.
· Proficient in the use of modern document management and communication tools.
· Participation in RA and QA professional upgrade seminars.
Reports To: Vice President QA/RA