Especialista Asuntos Reg Sr

Senior Regulatory Affairs Specialist At Medtronic you can begin a life‑long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Cardiac surgery represents end stage treatment in the care continuum for many cardiovascular diseases and this OU provides an intimate relationship with the Cardiac Surgeon and Cardiac OR by offering an unparalleled depth and breadth of portfolio. Key Technologies Surgical heart valves Cardiac OR solutions (e.g., blood management, cannulae) Extracorporeal life support Coronary artery bypass grafting (CABG) solutions Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident — we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions. This position will be on‑site at the Tijuana Campus. Careers that Change Lives The Senior Regulatory Affairs Specialist is responsible for assessment of device changes for regulatory implications and for performing regulatory activities in support of implementing these device changes. Additionally, the Senior Regulatory Affairs Specialist is responsible for developing global regulatory strategies, preparing U.S. and EU submissions and maintaining global product approvals. Responsibilities Team with operating unit Regulatory Affairs Specialists (RAS) and international regulatory team to provide regulatory support of changes to existing products. Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies. Define the regulatory strategy and manage regulatory submission activities for product maintenance for existing approved products. Provide support to currently marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval. Interact directly with FDA/Notified Body and 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, audits, etc., as needed. Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel. Provide business and product information to international regulatory team to enable development of strategies and requirements and communicate that information to business teams. Ensure personal understanding of all quality policy/system items that are personally applicable. Follow all work/quality procedures to ensure quality system compliance and high-quality work. Must Have: Minimum Requirements Bachelor’s degree required (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. - *****(h)( 4)(iii)(A) Minimum of 4 years of experience in regulatory affairs, or related field, in the medical device industry Advanced English Nice to Have (Preferred Qualifications) Advanced degree in a scientific discipline (engineering, physical/biological or health sciences). Proficiency in assessing changes to labeling, design, materials and manufacturing for impact to US and EU requirements Experience with 510(k)/IDE/PMA device product submissions and EU regulations (MDR) Experience with FDA and international regulatory agency requirements Effective interpersonal skills and team member. Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills. Ability to effectively manage multiple projects and priorities. Proficient computer skills. Project management skills. Excellent oral and written skills. Excellent analytical thinking skills. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package. A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain — #J-18808-Ljbffr