Job requirements and application form

The Regulatory Affairs (RA) Manager is responsible for coordinating regulatory activities for the business portfolio during product development and launch. The role focuses on establishing global regulatory strategies, obtaining and maintaining medical device market approvals in key target markets, and collaborating with global counterparts to align and execute a consistent regulatory approach. In this position you will be asked to: •Facilitate development of regulatory plans for new product development projects, novel technologies or markets segments. •Responsible for development, coordination, preparation, and maintenance of US FDA medical device submissions such as Pre-Submissions, 510ks and communicate with FDA reviewers as needed. •Where designated, responsible for development, coordination, preparation, and maintenance of medical device submissions for Canadian Medical Device License submissions and EU medical device Technical Files under Regulation (EU) 2017/745. Lead development of responses to regulatory authorities’ requests for additional information. •Interface with International Submission Management, Regulatory Affairs Team to support preparation of dossiers for registration for other global markets such as Japan, Asia Pacific region, Middle East region, etc. •Keep abreast of changes and proposed changes to the worldwide regulatory requirements related to our products and processes. May be tasked to advise management of changes and communicate regulatory initiatives or changes to other staff. •Responsible for maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information and to provide reports to management concerning current, pending, and future approvals to management. •Provide support for cross functional initiatives including manufacturing engineering, quality assurance, product development, and clinical affairs as required to assure regulatory compliance •Interface with global regulatory counterparts to ensure consistency across the function.

•B.Sc. or equivalent degree in science, engineering, or related fields. Master degree desirable. •5-10 years working in medical device industry. •Experience and competency designing, writing, reviewing and submission of regulatory filings (e.g. 510(k), CE Mark etc.) and correspondence and/or approvals is required, in a space aligned to the product portfolio. •Experience managing the submission process for global regulatory approvals. •Experience supporting end-to-end product lifecycle management for products within the product portfolio in major markets, such as North America, EMEA, Japan, China. •Experience defining global regulatory strategy for a portfolio of products, in a space aligned to the product portfolio, in collaboration with functions across the business. •Knowledge of FDA medical device regulations and guidance, Medical Device Regulation (EU) 2017/745, ISO 13485 Quality System standard, and other applicable international regulations, guidance, and standards. •Good knowledge of product and process verification and validation, and risk management. •Ability to think critically, using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems. •Strong IT skills – experience with relevant regulatory system - RIM / PLM and basic Office applications (essential), including MS Office (Word, Excel, PowerPoint, Outlook, Teams) •Excellent writing and English grammar skills. •Proven ability to lead projects/work on assignments that are complex and sensitive in nature where independent action and initiative are required in resolving problems and developing recommendations. •Demonstrates the highest ethical standards, actively promotes trust, respect and integrity in all dealings both inside and outside the Company. Location: HaSharon District, Hybrid