text: Sr Regulatory Affairs Specialist - International at Medtronic in Carlsbad, CA 92008 | CareerCast.com
  2000095B
  The Senior Regulatory Affairs Specialist International is responsible for assisting with the development of strategies for worldwide governmental approval (with focus on OUS markets) to introduce new products to OUS market, maintain existing products, provide advice on regulatory requirements, prepares worldwide submissions and negotiates their approval with the agencies.In addition, this position also assists with the training of other regulatory affairs associates and provides work direction on international projects of large scale with significant business impact.
  Respiratory, Gastrointestinal Informatics (RGI) offers technologies to help with early detection and treatment of diseases and reduce complications to accelerate recovery from patient conditions.RGI focuses on expanding global access to therapies that improve clinical outcomes for gastrointestinal diseases and cancer, and patients with respiratory compromise.RGI also focuses on reducing complications through patient monitoring.
  **A Day in the Life / Responsibilities** :
  + Team with business unit Regulatory Affairs Specialists and international regulatory staffs to provide regulatory support for new products/therapies and changes to existing products. Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
  + Prepare international submissions for new products and product changes as required to ensure timely approvals for international market release. Review significant product submissions with manager and negotiate submission issues with agency personnel.
  + Provide support to currently-marketed products as necessary. This includes providing business project teams with country-specific requirements on labeling, applicable standards, product changes and documentation for changes requiring government approval, and supporting renewal activities as scheduled by international workplans.
  + Interact indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager.
  + Support regulatory compliance activities, including manufacturing site registration, GMP audit, post-market vigilance reporting, product recalls, etc., as required by international regulatory agencies. - Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.
  + Support development of strategies and requirements, and communicate that information to business teams. - Provide feedback and on-going support to product development teams for international regulatory issues and questions.
  + Ensure personal understanding of all quality policy/system items that are applicable to the position.Follow all work/ quality procedures to ensure quality system compliance and high-quality work.
  Bachelors degree with 4+ years of experience in regulatory affairs and/or the medical device industry ORAdvanced degree with 2+ years of experience in regulatory affairs and/or the medical device industry.