Quality Regulatory Manager

Title : RAQA Lead - Spain and Portugal Location : Barcelona, Spain ✉️ Contact : frankie@elemed.euThe companyAre you someone who has Iberia-wide regulatory experiences and are looking for the next step in your medical devices career at the EMEA level? Are you someone who likes to think creatively and prioritizes medical devices that are always accessible to patients and surgeons on the market? Do you like working with both active and non-active devices?Here is a rare and great opportunity to join an international leader in surgical technology and be part of this company’s regional growth strategy in Spain and Portugal and be visible at the EMEA-level. As the Regional QARA Lead for the IBERIAN region, you will be based at their Spain branch office in Barcelona, where they have centralised sales, marketing, customer success teams all in one place.This is a company-critical role and your past experiences in registrations can help the company to reach their business goals for the EMEA region.This exciting position will give you the opportunity to work in a diverse international environment.You will be responsible for the quality system of the sales office in Barcelona as well as supporting the registrations for Spain. Furthermore, you are part of the EMEA Quality Assurance and Regulatory affairs team, for this region you will be responsible for collecting clinical data from surgeons to assist the HQ in the US with clinical surveillance.In this role you will report directly to the Sr Director Quality Assurance and Regulatory Affairs InternationalYour responsibilities:Maintain the Quality Management System for their Spanish Organization Work with the Regional Commercial leader to ensure the medical device portfolio remain commercially available and compliant Manage Post-Market Surveillance (PMS) operations and PMCFs Leading clinical data collection and surgeon feedback processes for submission and PMCFs Prepare and lead the quality management review meetings Training and coaching people in RAQA functions in other EMEA offices on the procedures and processes Identify local regulatory requirements and lead impact assessment which is driving quality management system changes Execute Local regulatory registrations where necessary Supporting internal and external audits EMEA regulatory affairs activities concerning importer and authorized representative requirementsYour qualifications:At least 5 years in a quality assurance or regulatory affairs role in the medical device industry Led the RAQA operations or projects for medical devices Fluent written & spoken in Spanish and English (bonus if Portuguese and Catalan as well) Office-presence 3 days per week in Barcelona city-centre✉️ If you are interested in this exciting role, please send your application directly tofrankie@elemed.euWould you like to find out more about our open opportunities? Visit https://www.elemed.eu/vacancies/Please note: Only candidates meeting the requirements set out in the role profile above, will be considered in the application process. Due to the high volume of applications we receive, our team might not be able to contact each applicant individually regarding the status of their application. If you do not hear from us after 10 days, please consider your application unsuccessful. ___________________________________________________________________Elemed is Europe’s leading MedTech technical recruiter.We serve within the Medical device, diagnostic and combination device arena, working with Managers up to VP of Quality and Regulatory. Our team helps medical device experts of today become leaders of tomorrow.We won Best International Recruitment Agency at the Recruiter Awards 2021. At Elemed, we recruit exceptional people that solve regulatory and compliance problems, so patients can have access to safe, innovative and life-changing Medical Devices.Learn and develop as a regulatory, quality or clinical professional with 1:1 mentorship from a highly experienced mentor. Our mentors are some of the most inspirational and talented senior professionals in the medical device and IVD industry. We handpick your mentor and make the match based on your mentoring goals and their experience. Learn more >https://www.elemed.eu/elemedsmentoringacademy20/Join hundreds of fellow regulatory, quality and clinical professionals in Elemed’s RQC Network. Find the answers to 1000+ industry-related questions (including topics such as MDR, IVDR, PRRC, certification, validation and more), attend expert-led masterclasses and more. Learn more here > https://www.rqc.network/⚖️ We are an equal opportunity employer and value diversity at our company . We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.