Regulatory Affairs Manager - Abbott Diabetes Care Madrid, Community of Madrid Regulatory Affairs Manager - Abbott Diabetes Care Madrid Madrid, Community of Madrid, ES About AbbottAbbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:Career development with an international company where you can grow the career you dream of. A company named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This position works out of our Spain or Netherlands location in the Diabetes division. We're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology. As the Regulatory Affairs Manager, you'll have the chance to manage the people under your responsibility, helping them to align the priorities and acting as a coach in the ethical way with the objective of work towards excellence. Responsible for developing team talent. You wil coordinate preparation of well organized, complete, and scientifically sound regulatory submissions. Interface directly with various regulatory agencies, as required, to facilitate the review and approval of regulatory applications and to address queries. Exercise judgement within generally defined practices and departmental standard operating procedures. Accountable for budgets, schedules, and ensuring compliance to divisional and corporate policies as required. Develop and maintain strong and effective relations with internal/external personnel. What You'll DoEnsures that all activities are performed in compliance with quality system and regulatory requirements. Maintains the effectiveness of the Quality System at the site in accordance with divisional and corporate requirements and applicable regulations. Works with Regulatory leadership to develop and implement regulatory strategies for product introductions and modifications per agreed scheduleAdvising in the interpretation and application of MD and IVD regulations as well as the planning and implementation of new and updated regulationsMonitor and report on regulatory intelligenceMaintains strong communication and working relationships with all departments across division sites, Third Party Manufacturers, suppliers, and external personnel when required. Maintain a high level of technical understanding with all new products. Provides strategic regulatory input (including all feasible alternatives and associated risks) and drives cross-functional alignment with issues that could have regulatory ramificationsManages the preparation of registration documents as required for international marketsProvides input and comment on regulations and standards which may affect division productsProvides input and comment on cross-divisional discussions and projectsAccountable for cross-functional project communicationAccountable for budgets and schedulesManage multiple concurrent projects and personnel to effectively support the businessBuild partnerships and mutual respect with regulatory authorities (e. G. , Notified Body, Competent Authorities and others). Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Hire and retain a diverse, highly qualified staff and provides ongoing performance feedback. Maintains a safe and professional work environment. Support reimbursement / tender requirements. Support the different teams and affiliates for new requirements implementationRequired QualificationsBachelor's Degree Minimum 5 years of Medical device / In vitro Medical device regulatory experience including submissions for new products and product changes in the medical device industryTo support our complex product lines, a solid scientific knowledge is required. English: ProficiencyPreferred QualificationsExcellent organization skills required. Technical backgroundAbility to work proactively in a highly matrix and geographically diverse business environmentKnowledge of European regulations and standards affecting Medical Devices and In Vitro Medical DevicesExperience of working within the requirements of ISO 13485, the Medical Devices Directive (93/42/EEC), the IVD Directive (98/79/EC), Medical Device Regulation (2017/745) and/or In-vitro Diagnostic Regulation (2017/746) and local regulations. Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at, on Facebook at and on Twitter @AbbottNews and @AbbottGlobal. Job SummaryJob number: 31053128Date posted : 2023-04-17Profession: Regulatory AffairsEmployment type: Full time#J-18808-Ljbffr
