Regulatory Affairs Specialist II

Ensure compliance with global regulations and regulating agencies. Interpret the intent of regulations and policies and provide such information to project teams and management. Develop and implement regulatory strategies and processes to ensure timely global commercialization of products/changes in compliance with applicable regulations and standards. Develop 510k/PMA submissions and US assessments for class II and III medical devices. Develop Technical Documentations and EU assessments. Conduct submission negotiations with the FDA/European Notified Bodies as needed, including pre-submission identification of requirements and strategy and post submission negotiations to ensure timely approval. Maintain proficiency on regulatory requirements and develop and maintain rapport with FDA/ Notified Body reviewers, project team members. Represent RA in life cycle management project team. Provide continuing regulatory education and dissemination of regulatory information to the product development, marketing, and clinical groups. Manage the generation of documentation to be submitted to worldwide governmental regulatory agencies in order to secure approvals to market products manufactured and/or distributed by client affiliates. Work with others as a team player to successfully achieve strategy. Must be cooperative and work well with all functional groups. Responsible for communicating business related issues or opportunities to next management level. Responsible for following all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition. Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. Performs other duties assigned as needed. Qualifications A minimum of Bachelor’s Degree in Engineering, Physical or Biological science or related field is required. A minimum of 4 years of experience in Regulatory Affairs or other related discipline in the medical device industry is required. (Or Advanced degree with 2 years of experience in Regulatory Affairs or other related discipline in the medical device industry is required) Experience of US and/or EU submission is preferred. Experience in the cardiovascular/cardiology field is preferred. International clinical and regulatory experience desired. RA lead on a cross-functional teams (negotiation, leading RA strategy globally) is preferred. Strong negotiation/communication skill is required. Strong project management skill is required. Strong interpersonal, organizational, and problem-solving skills are required. Strong presentation skill is required. This position will be located in Irvine, CA.. Domestic and international travel up to 10% may be required. #J-18808-Ljbffr