Descripción de la oferta
Company ProfileFujifilm plays a vital role in Europe, operating through a network of over 50 group companies and branches, with a dedicated and passionate workforce of more than 7,000 individuals contributing to R&D, manufacturing, sales, and services. At the heart of our strategic operations lies FUJIFILM Europe GmbH in Ratingen, Germany, serving as our headquarters, overseeing activities across the entire EMEA region.Guided by our Group Purpose, \"Giving Our World More Smiles,\" we are passionately driving innovation and revolutionizing our business in diverse industries across Europe. These include medical technology, biopharmaceuticals, electronic materials, industrial products, chemicals, graphic systems, optical devices, data storage, and all realms of photography.By embodying our Group Purpose, we strive to create products and services that not only bring joy and fulfillment to our customers but also enhance the well-being of our planet and society at large.To learn more about our impactful initiatives and the positive changes we are making, please visit fujifilm.com.Who are we looking for?At Fujifilm Spain, we are seeking a Quality Assurance & Regulatory Affairs Specialist to join our team at the Alcobendas offices, with 3-5 years of experience in legal roles within multinational companies, preferably in the healthcare sector. This role will be part of our Legal Department and will focus on ensuring compliance with quality and regulatory standards in a highly regulated market.What will your responsibilities be?Manage and maintain compliance with quality and regulatory requirements applicable to healthcare products and services.Coordinate and participate in cross-functional projects related to regulatory affairs and quality management.Support and lead internal and external audits, including renewal, expansion, and acquisition of certifications such as ISO standards.Collaborate closely with European quality teams, ensuring alignment and effective communication.Provide legal and regulatory advice to support business operations and product lifecycle management.Monitor changes in relevant regulations and standards, ensuring timely implementation within the company.Prepare and review documentation required for regulatory submissions and certifications.What skills and qualifications do we expect from you?Degree in Law, Pharmacy, Chemistry, Environmental Sciences or related field.3-5 years of professional experience in regulatory affairs, preferably within multinational companies in the healthcare sector.Proven experience and training in quality management and regulatory compliance.Strong project management skills with experience coordinating and participating in multidisciplinary projects.Very high level of English (C1/C2), both written and spoken, to ensure effective coordination with European teams.Experience participating in audits and managing certification processes (ISO 9001, ISO 14001, ISO 13485, MDR and others).Excellent communication, analytical, and problem-solving skills.Ability to work independently and as part of a team in a dynamic, fast-paced environment.Proactive attitude and strong attention to detail.Transversal and adaptive profile, capable of adjusting to the changing demands of the business and collaborating across departments. What do we offer?
