Quality & Regulatory Affairs Manager
hace 7 días
The company ¿Es usted el solicitante adecuado para esta oportunidad? Descúbralo leyendo el resumen del puesto a continuación. Are 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? 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. 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 International 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 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 EMEA regulatory affairs activities concerning importer and authorized representative requirements 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 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. #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. Join hundreds of fellow regulatory, quality and clinical professionals in Elemed’s RQC Network. We are an equal opportunity employer and value diversity at our company #J-18808-Ljbffr
-
Quality & Regulatory Affairs Manager
hace 1 semana
Barcelona, España Elemed A tiempo completoThe companyAntes de solicitar este puesto, por favor, lea la siguiente información sobre esta oportunidad que encontrará a continuación.Are 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...
-
Quality & Regulatory Affairs Manager
hace 7 días
Barcelona, España Elemed A tiempo completoThe company¿Es usted el solicitante adecuado para esta oportunidad? Descúbralo leyendo el resumen del puesto a continuación.Are 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...
-
Technical/regulatory Affairs Manager
hace 1 semana
Barcelona, España Page Personnel España A tiempo completoMaintain up-to-date and follow all Company Quality Assurance System ensuring alignment with regulatory requirements as per Quality Standard EN ISO 13485:2016, the Medical Device Directive 93/42/EEC and new Regulation (EU) 2017/745 requirements - Manage the EC Certificates, the EN ISO 13485 Certificate and the Manufacturer License issued by NB 0318-AEMPS...
-
Regulatory Affairs Manager
hace 1 día
Barcelona, Barcelona, España Hezuo Ltd A tiempo completoAsRegulatory Affairs Manager, you'll play a pivotal role in supporting the geographical expansion of adietary supplement ingredient business. Based inBarcelona, you'll coordinate regulatory activities that ensure timely and compliant product registrations, authorizations, marketing & scientific communication across international markets, while providing...
-
Global Regulatory Affairs Manager
hace 17 horas
Barcelona, España MCR International A tiempo completoDescripción del Trabajo / Job Description - MFC-2402-62 GLOBAL REGULATORY AFFAIRS MANAGER BARCELONA Position Summary Innovative international specialty pharma Company that invests in the development of new treatments for patients through partnerships with third parties. A broad therapeutic portfolio provides help to many patients in need. Although the...
-
Regulatory Affairs Manager
hace 2 semanas
Barcelona, España JR Spain A tiempo completoSocial network you want to login/join with: Regulatory Affairs Senior Manager, Barcelona EU work permit required: If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Pharmalex, a Cencora company, is looking for a Senior Manager Regulatory Affairs to join...
-
Regulatory Affairs Officer Pharma
hace 16 horas
Barcelona, España Page Personnel España A tiempo completoReporting to the Regulatory Affairs Manager, he/she will be responsible for preparing, managing and submitting the documentation required within a registration dossier to the Health Authorities, in accordance with the current legislations. - Report to Head of Regulatory Department - Capability to maintain fluid and frequent contact with the client & to find...
-
Regulatory Affairs Manager
hace 2 días
Barcelona, España Jordan martorell s.l. A tiempo completoJob Title:¿Tiene las habilidades necesarias para este puesto? Lea todos los detalles a continuación y presente su candidatura hoy mismo.European Regulatory Affairs ManagerLocation:Madrid, Spain - HybridRemuneration:Competitive salary and packageRegulatory Affairs Manager opportunity working for an established pharmaceutical company that specialises in...
-
Regulatory Affairs
hace 1 semana
Barcelona, España Hays A tiempo completo**Tu nueva empresa** Nuestro cliente es una empresa en pleno crecimiento que se dedica a la investigación de ingredientes patentados para su aplicación en diferentes sectores: alimentación, salud y nutrición. **Tu nuevo puesto** Estamos buscando perfiles como Regulatory Affairs Manager & Regulatory Affairs Technician, cuyo objetivo será el de...
-
Quality Regulatory Manager
hace 1 semana
barcelona, España elemed A tiempo completoTitle : RAQA Lead - Spain and Portugal Location : Barcelona, Spain ✉️ Contact : The company Are 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...
