Arthrex, Inc. es una empresa global de dispositivos médicos y líder en desarrollo de nuevos productos y educación médica. Somos una empresa privada que se esfuerza por cumplir nuestra misión corporativa de ayudar a los c…
Requisition ID: 65850 Title: Product Management, Orthopedic Fluid Management Arthrex, Inc. is a global medical device company and a leader in new product development and medical education within the orthopedic field. Our…
Wir gehören zu den weltweit führenden Unternehmen in den Bereichen Orthopädie, Arthroskopie, Sportmedizin und Orthobiologika. Getreu unserer Mission „Helping Surgeons Treat Their Patients Better“ entwickeln wir seit über…
Skills: 3D CAD Software, CT Scan Processing, Segmentation, Anatomical Landmark Identification, Medical Device Standards
Requisition ID: 66891 Title: Warehouse Associate II - ALCE Arthrex Inc. is hiring a Warehouse Associate II to work at our Arthrex Logistics Center East in Fort Myers, FL to successfully receive and ship company products …
Skills: SAP, RF Scanner, Vocollect, Inventory Control, Shipping and Receiving
Construire, accompagner et faire aboutir une vente complexe à fort enjeu ! Responsable Commercial Equipement F/H Secteur Centre-Ouest - Bordeaux (33) / Limoges (87) Chez Arthrex, la performance commerciale repose sur la …
Wir gehören zu den weltweit führenden Unternehmen in den Bereichen Orthopädie, Arthroskopie, Sportmedizin und Orthobiologika. Getreu unserer Mission „Helping Surgeons Treat Their Patients Better“ entwickeln wir seit über…
Skills: 3D CAD Software, CT Scan Segmentation, Pre-operative Planning, Quality Control, Medical Device Standards
Requisition ID: 66592 Title: Product Manager, Associate - Arthroplasty Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively se…
Requisition ID: 65940 Title: Supervisor - Milling and Drill Cell Arthrex Manufacturing in Ave Maria, FL is looking to find someone to lead a high-performing team across Milling, Drill Cell, and EDM in this Supervisor – C…
Skills: Leadership, Lean Manufacturing, Process Improvement, Production Scheduling, Staffing Management
Requisition ID: 66610 Title: Product Marketing Management - Arthroplasty Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively …
Wir gehören zu den weltweit führenden Unternehmen in den Bereichen Orthopädie, Arthroskopie, Sportmedizin und Orthobiologika. Getreu unserer Mission „Helping Surgeons Treat Their Patients Better“ entwickeln wir seit über…
Frechen, North Rhine-Westphalia, Germany · On-site
Senior
Wir gehören zu den weltweit führenden Unternehmen in den Bereichen Orthopädie, Arthroskopie, Sportmedizin und Orthobiologika. Getreu unserer Mission „Helping Surgeons Treat Their Patients Better“ entwickeln wir seit über…
Requisition ID: 66602 Title: Supervisor (Packaging)- Ave Maria, FL. Arthrex Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex Manufacturing is a…
Medical Education Clinical Specialist - New Zealand Benefits & Highlights: Competitive base salary + private health insurance + bonus Excellent leadership, mentoring support with ongoing training & development Future car…
Skills: Medical Education, Clinical Support, Event Management, Orthopaedic Knowledge, Surgical Technique Training
Outbound Coordinator / Mitarbeiter Logistik (a) 100% in Belp
Bern, Bern, Switzerland · On-site
Senior
Deine Aufgaben Prozessverantwortung für die Outbound-Prozesse Stellvertretung des Inbound Coordinators bei dessen Abwesenheit Aktive Mitarbeit im Wareneingang Warenausgang: Übergabe von Ware und Papieren bei Sondertransp…
Skills: Outbound Process Management, SAP MM, SAP ERP, Inventory Management, Order Picking
Outbound Coordinator - Mitarbeiter/in Logistik 100% in Belp
Bern, Bern, Switzerland · On-site
Senior
Deine Aufgaben Prozessverantwortung für die Outbound-Prozesse Stellvertretung des Inbound Coordinators bei dessen Abwesenheit Aktive Mitarbeit im Wareneingang Warenausgang: Übergabe von Ware und Papieren bei Sondertransp…
Skills: Outbound Process Management, SAP MM, SAP ERP, Inventory Management, Order Picking
Santiago, Santiago Metropolitan Region, Chile · On-site
Mid level
Arthrex, Inc. es una empresa global de dispositivos médicos y líder en desarrollo de nuevos productos y educación médica. Somos una empresa privada que se esfuerza por cumplir nuestra misión corporativa de ayudar a los c…
Arthrex, Inc. é uma empresa global de dispositivos médicos e líder em desenvolvimento de novos produtos e educação médica em ortopedia. Junte-se à nossa talentosa equipe em uma empresa global de dispositivos médicos foca…
Ihre Aufgaben Sie beraten eigenverantwortlich unsere Fachbereiche (IT & International Sales) in einem End2End Prozess in allen Talent Acquisition Themen auf Augenhöhe und führen mit Ihrer Expertise sowohl interne als auc…
We are one of the world’s leading companies in the fields of orthopedics, arthroscopy, sports medicine, and orthobiologics. True to our mission “Helping Surgeons Treat Their Patients Better,” we have been developing inno…
Skills: Contract Management, Compliance, Administrative Support, Microsoft Office, Organizational Skills
Wir gehören zu den weltweit führenden Unternehmen in den Bereichen Orthopädie, Arthroskopie, Sportmedizin und Orthobiologika. Getreu unserer Mission „Helping Surgeons Treat Their Patients Better“ entwickeln wir seit über…
Skills: Contract Management, Compliance, Administrative Support, Microsoft Office, Organization
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
Full-time
Posted 17d ago
~40 hrs/week
Spanish
Responsibilities
Provide intermediate-level international regulatory support to maintain and obtain medical device approvals. Coordinate with internal departments to compile technical documentation and manage regulatory queries from subsidiaries and distributors.
Requirements
The candidate must be able to handle regulatory submissions, technical reviews, and the management of certificates for foreign governments. Experience in coordinating with Engineering, R&D, and Quality teams is essential.
Full job description
Arthrex, Inc. es una empresa global de dispositivos médicos y líder en desarrollo de nuevos productos y educación médica. Somos una empresa privada que se esfuerza por cumplir nuestra misión corporativa de ayudar a los cirujanos a tratar mejor a sus pacientes™. Estamos comprometidos a brindar una calidad inigualable a los profesionales de la salud que usan nuestros productos y, en última instancia, a los millones de pacientes cuyas vidas impactamos.
Objetivo principal: Brindar soporte regulatorio internacional de nivel intermedio para asegurar el mantenimiento y la obtención de aprobaciones regulatorias de dispositivos médicos, trabajando bajo supervisión general y en cumplimiento con los requisitos regulatorios locales y corporativos
Deberes y responsabilidades principales:
Responder consultas de subsidiarias y distribuidores para facilitar registros de nuevos productos, renovaciones y re-registros regulatorios.
Coordinar con áreas internas (Ingeniería, I+D, Manufactura y Calidad) la recopilación de información técnica requerida para sometimientos regulatorios.
Dar soporte en la preparación y compilación de documentación regulatoria para cambios de diseño, manufactura, etiquetado y requerimientos aduaneros.
Realizar revisión técnica básica de datos y reportes antes de su envío a autoridades regulatorias, asegurando consistencia y trazabilidad.
Gestionar solicitudes de Certificados para Gobierno Extranjero, Certificados de Libre Venta y Certificados de Fabricación.
Mantener actualizadas las bases de datos y archivos regulatorios.
Brindar soporte continuo a subsidiarias y distribuidores para la resolución de consultas regulatorias rutinarias.
Identificar y comunicar cambios regulatorios aplicables en el país o región asignada.
Participar en auditorías internas y externas según sea requerido.
Apoyar en la elaboración o actualización de procedimientos, instructivos y documentación del área.
Mantiene estrecha comunicación con el equipo Corporativo para el manejo de información, requerimientos, necesidades y actividades correspondientes al área.
Estamos comprometidos en tratar a todos los y las solicitantes de manera justa y no discriminamos por motivos de raza, nacionalidad, edad, sexo, características físicas, origen social, discapacidad, afiliación sindical, religión, estado civil, embarazo, orientación sexual, identidad de género, expresión de género o cualquier criterio ilegal según corresponda a ley.
Related keywords
Medical DevicesRegulatory AffairsProduct RegistrationTechnical FilesFree Sale CertificatesManufacturing CertificatesDesign ChangesLabeling RequirementsCustoms RequirementsInternal AuditsExternal AuditsCompliance
Arthrex is a global medical device company and leader in new product development and medical education in orthopedics. With a corporate mission of Helping Surgeons Treat Their Patients Better®, Arthrex has pioneered the field of arthroscopy and developed more than 1,000 innovative products and surgical procedures each year to advance minimally invasive orthopedics worldwide.
Arthrex continues to experience unprecedented growth and demand for our products throughout the world; however, we remain a privately held company with a family business culture that is committed to delivering uncompromising quality to the health care professionals who use our products and, ultimately, the millions of patients whose lives we impact.
Arthrex’s global headquarters is located in Naples, FL, with regional offices around the world in Munich, Germany (EMEA), Mexico City, Mexico (LATAM) and Singapore (APAC). Additionally, subsidiary offices and distribution centers are located throughout the Eastern and Western Hemispheres.
We invite you to learn more about Arthrex and the positive contributions we are making to medicine and the communities we serve around the world. See Arthrex’s global locations: https://www.arthrex.com/corporate/locations
Offices: 1 Arthrex Way, Naples, Florida 34108-1945, US · 14550 Plantation Road, Fort Myers, Florida 33912, US · 168 Brea Canyon Rd., Building 13, City of Industry, California 91789, US · 460 Ward Drive, Santa Barbara, California 93111, US · 6875 Arthrex Commerce Drive, Ave Maria, FL 34142, US
Orthopedic Surgical ProceduresOrthopedic Medical EducationOrthopedic Surgical ProductsMedical Device InnovationMedical Device ManufacturingArthroscopy & Sports MedicineTotal Joint ArthroplastyImaging & Resectionorthopedicsorthopedic medical device
Arthrex is a global medical device company and leader in new product development and medical education in orthopedics. With a corporate mission of Helping Surgeons Treat Their Patients Better®, Arthrex has pioneered the field of arthroscopy and developed more than 1,000 innovative products and surgical procedures each year to advance minimally invasive orthopedics worldwide.
Arthrex continues to experience unprecedented growth and demand for our products throughout the world; however, we remain a privately held company with a family business culture that is committed to delivering uncompromising quality to the health care professionals who use our products and, ultimately, the millions of patients whose lives we impact.
Arthrex’s global headquarters is located in Naples, FL, with regional offices around the world in Munich, Germany (EMEA), Mexico City, Mexico (LATAM) and Singapore (APAC). Additionally, subsidiary offices and distribution centers are located throughout the Eastern and Western Hemispheres.
We invite you to learn more about Arthrex and the positive contributions we are making to medicine and the communities we serve around the world. See Arthrex’s global locations: https://www.arthrex.com/corporate/locations
Offices: 1 Arthrex Way, Naples, Florida 34108-1945, US · 14550 Plantation Road, Fort Myers, Florida 33912, US · 168 Brea Canyon Rd., Building 13, City of Industry, California 91789, US · 460 Ward Drive, Santa Barbara, California 93111, US · 6875 Arthrex Commerce Drive, Ave Maria, FL 34142, US
Orthopedic Surgical ProceduresOrthopedic Medical EducationOrthopedic Surgical ProductsMedical Device InnovationMedical Device ManufacturingArthroscopy & Sports MedicineTotal Joint ArthroplastyImaging & Resectionorthopedicsorthopedic medical device