![HIGH TECHNOLOGY PRODUCTS](https://media.trabajo.org/img/noimg.jpg)
Regulatory Affairs Engineer
hace 1 semana
Are you looking for experience within a Regulatory department? This is your opportunity, Sinclair are currently recruiting for a Regulatory Affairs Engineer at their Barcelona office for the Energy Devices division.
The role
Working within the Regulatory Affairs Team, the Junior Regulatory Affairs Specialist assures regulatory requirements are met for new product development and design changes to established legacy devices.
Reporting to the Team Leader Registration & RA Engineer, the position holder assures the design and development processes contains the correct regulatory requirements and supporting evidence.
Working closely with Research and Development and other business departments, the position holder will also ensure the type testing certification such as electrical compatibility and compliance to product specific standards and directives are in place.
This assures the integrity of the design history file and technical documentation as a precursor to country specific registration(s).
This position provides and contributes to the Regulatory deliverables from internal Research and Development projects, contributes to providing Regulatory solutions to business requirements and changes to the regulatory landscape.
This position provides operational Regulatory support to cross-functional teams, ensuring compliance to the UK, European and International country specific legislations.
Responsibilities:
- Preparation of technical documentation and submission packages (STEDs) for the filing of premarket global regulatory submissions in line with company strategy.
- Establish and maintain regulatory information systems, technical documentation files and routine reports.
- Collaborate with global Regulatory Affairs teams to understand existing and/or new regulatory requirements/guidelines and standards as they relate to company products and procedures.
- Ensure regulatory compliance to global requirements and company policies.
- Support new product development activities.
- Review documents and product changes for regulatory submission impact.
- Liaise with and assist vigilance team with respect to requirements of product dossiers and relevant post marketing activities as and where necessary.
- Assist and support inspections and audits.
- Valuable: 1 year' experience in Regulatory Affairs within a Medical Device or Aesthetics organisation.
- Valuable: Working knowledge of the Medical Device Regulation and Medical Device Directive.
- Excellent attention to detail when reviewing and preparing documentation.
- Organised, targetorientated, flexible, good time management skills.
- Strong written and oral communication skills
- Excellent attention to detail when reviewing and preparing documentation.
- Fluency in written and spoken English.
-
Corporate Head of Regulatory Affairs
hace 2 meses
Distrito de Sant Martí, Barcelona, España International Staffing Consultants, Inc. A tiempo completoCorporate Head of Regulatory AffairsLocation: Barcelona or remote but open to commute.Job PurposeEnsure that the worldwide regulatory strategies are clearly supported and implemented in the product development, commercialization and life cycle management of the medicinal products.Major AccountabilitiesDevelopment of international regulatory strategies and...
-
Regulatory Solutions Consultant
hace 1 semana
El Prat de Llobregat, Barcelona, España Clarivate A tiempo completoWe are looking for a Regulatory Solutions Consultant to join our Clinical and Regulatory Team. This is an amazing opportunity to work on regulatory consulting projects. We have a great skill set in data monitoring, content writing and consulting for multiple domains- regulatory submissions, clinical trials, marketing authorization applications (MAA),...
-
Regulatory & Product Compliance Expert
hace 1 semana
Cornellà de Llobregat, Barcelona, España Master Builders Solutions A tiempo completoJoin Us as a Regulatory Expert - Deputy for Head of Product Stewardship Are you passionate about ensuring the safety in chemical products? Do you thrive in a dynamic, international environment where compliance is paramount? If so, we have the perfect opportunity for youAbout Us:At Master Builders Solutions, safety always comes first. We are a global leader...
-
Consultant RA QA
hace 1 semana
El Prat de Llobregat, Barcelona, España Clarivate A tiempo completoWe are looking for a RAQA Consultant ( Regulatory Affairs / Quality Assurance ) to join our Clinical and Regulatory Team. This is an amazing opportunity to work on regulatory and quality consulting projects. We have a great skill set in data monitoring, content writing and consulting for multiple domains- regulatory submissions, clinical trials, marketing...
-
TEMP Regulatory Affairs Specialist EMEA
hace 1 semana
Cornellà de Llobregat, Barcelona, España ZimVie US Corp LLC A tiempo completoWe are ZimVie, a leading global life sciences organization dedicated to enhancing everyday life through the advancement of clinical technology to enhance smiles, functionality, and confidence in patients. Our company has a rich history of trusted brands, products, and clinical research, all made possible through a culture of inclusivity and collaboration...
-
TEMP Regulatory Affairs Specialist EMEA
hace 1 semana
Cornellà de Llobregat, Barcelona, España ZimVie US Corp LLC A tiempo completoWe are ZimVie, a renowned global player in life sciences dedicated to enriching daily life through advancements in clinical technology, enhancing patients' smiles, functionality, and confidence. Our company prides itself on a rich heritage of trusted brands, products, and scientific backing, fostered by an inclusive and collaborative environment that...
-
Asistente de Asuntos Regulatorios
hace 1 semana
Hospitalet de Llobregat, Barcelona, España Synergie A tiempo completoRequisitos Experiência mínima de un año en posiciones similares en gestión de calidad y gestión de normativas regulatorias. Ingles fluidoCompetencias/Habilidades:Capacidad Analítica.Capacidad de Aprendizaje.Comunicación.Colaboración.Flexibilidad.Orientación Cliente.Iniciativa.Planificación.Orientación a Resultados.DescripciónSynergie ETT,...
-
Auditor & Product Expert for IVD Expert Devices
hace 1 semana
El Prat de Llobregat, Barcelona, España TÜV Rheinland A tiempo completoJob Description As a Product Specialist/Expert you evaluate IVD Expert medical products in accordance with European guidelines and standards. You are responsible for the review of the technical documentation of selected product groups in non-active products area in your field of expertise – Sterilize and non-sterilize devices, Implantable devices as...
-
Auditor & Product Expert for Non-active Devices
hace 1 semana
El Prat de Llobregat, Barcelona, España TÜV Rheinland Group A tiempo completoAs a Product Specialist/Expert you evaluate Non-Active medical products in accordance with European guidelines and standards. You are responsible for the review of the technical documentation of selected product groups in non-active products area in your field of expertise - Sterilize and non-sterilize devices, Implantable devices as orthopedic and dental...
-
Head of Translational Medicine and Early Clinical
hace 1 semana
Sant Feliu de Llobregat, Barcelona, España Almirall A tiempo completoFecha: 01-mar-2023- Ubicación: SFEL - R&D SANT FELIU DE LLOBRMission:Leads the Early Clinical Development Group within Global Clinical Development, providing a strong link between Disease Biology and Late Phase Development.Functions and responsibilities:Reporting to the Executive Director of Global Clinical Development, the Head of Translational Medicine is...
-
Statistician R&d
hace 1 semana
Sant Feliu de Llobregat, Barcelona, España Almirall A tiempo completoDate:14 Nov 2023Location: SFEL - R&D SANT FELIU DE LLOBR, ES, ES - SpainCompany:AlmirallMission:The Junior Statistician will be responsible of the design and statistics of clinical trials and clinical development projects within Almirall. The Junior Statistician will partner with senior scientists in clinical (Global Development and Global Medical Affairs),...
-
Senior Clinical Scientist
hace 1 semana
Sant Feliu de Llobregat, Barcelona, España Almirall A tiempo completoFecha: 17 jun Ubicación: SFEL - R&D SANT FELIU DE LLOBRMission:The Senior Clinical Development Scientist is an important member of the Global Project Team, Strategic Clinical Team and Clinical Study Teams working cross functionally with other R&D and non-R&D departments such as Regulatory and Patient Safety, Disease Biology, Global Market Access and...
-
Manager, Sanctions Control
hace 1 semana
El Prat de Llobregat, Barcelona, España DOW JONES A tiempo completoDescription Job Title: Manager, Sanctions Control & Ownership, Risk & Compliance Research About the Role Dow Jones Risk & Compliance is a global provider of third-party risk management and regulatory compliance solutions. We deliver data, research tools and services to help our clients meet anti-money laundering, anti-bribery, anti-corruption and...
-
Hospitalet de Llobregat, Barcelona, España Amgen A tiempo completoCareer CategoryGovernment AffairsJob DescriptionIf you feel like you're part of something bigger, it's because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and...
-
Senior R&D Packaging Engineer
hace 1 semana
Sant Adrià de Besòs, Barcelona, España General Mills A tiempo completoGreat things are happening in the Europe and Australia (EUAU) region. Each day, our 2,500 plus colleagues bring their passion to our offices, manufacturing sites, R&D center, and commercial/distributor markets across Europe, Australia, and New Zealand. We are energized by over 150 years of bringing people together with the food they love. With beloved...
-
Statistical Programmer 1
hace 1 semana
Sant Feliu de Llobregat, Barcelona, España Almirall A tiempo completoDate:9 Nov 2023Location: SFEL - R&D SANT FELIU DE LLOBR, ES, ES - SpainCompany:AlmirallMission:Overview and analyze the required statistics for clinical studies carried out by Almirall S.A.Tasks and Responsibilities:Participation in clinical trials and clinical development projects Revise study protocols. Revise Study critical documentation: Case Report Form...
-
Regulatory Affairs Engineer
hace 4 semanas
Esplugues de Llobregat, España HIGH TECHNOLOGY PRODUCTS A tiempo completoAre you looking for experience within a Regulatory department? This is your opportunity, Sinclair are currently recruiting for a Regulatory Affairs Engineer at their Barcelona office for the Energy Devices division. The role Working within the Regulatory Affairs Team, the Junior Regulatory Affairs Specialist assures regulatory requirements are met for new...
-
Factory Regulatory Affairs Manager
hace 2 semanas
l'Hospitalet de Llobregat, España Impress A tiempo completoDescription We are **Impress**. We believe everyone deserves a smile they’ll love. We are the **largest chain of ortho clinics with fully digital processes in Europe**. We have revolutionised the invisible orthodontic sector with the best team of professionals specialised in making people smile and using the latest technology for the diagnosis,...
-
Regulatory Affairs Analyst
hace 2 semanas
Sant Feliu de Llobregat, España Centrient Pharmaceuticals Netherlands A tiempo completoCentrient Pharmaceuticals is the leading manufacturer of beta-lactam antibiotics, and a provider of next generation statins and anti-fungals. We produce and sell intermediates, active pharmaceutical ingredients and finished dosage forms. We stand proudly at the centre of modern healthcare, as a maker of essential and life-saving medicines. With our...
-
Consultant RA QA
hace 1 mes
El Prat de Llobregat, España Clarivate A tiempo completoWe are looking for a RAQA Consultant ( Regulatory Affairs / Quality Assurance ) to join our Clinical and Regulatory Team. This is an amazing opportunity to work on regulatory and quality consulting projects. We have a great skill set in data monitoring, content writing and consulting for multiple domains- regulatory submissions, clinical trials,...
-
Consultant RA QA
hace 3 semanas
El Prat de Llobregat, España Clarivate A tiempo completoWe are looking for a RAQA Consultant ( Regulatory Affairs / Quality Assurance ) to join our Clinical and Regulatory Team. This is an amazing opportunity to work on regulatory and quality consulting projects. We have a great skill set in data monitoring, content writing and consulting for multiple domains- regulatory submissions, clinical trials,...
-
Safety & Regulatory Affairs Manager
hace 1 semana
Jerez de la Frontera, España Cosmewax A tiempo completoDescripción Buscamos un Técnico en Regulatory Affairs para nuestra sede de Jerez o Valencia. Las funciones que realizará son: - Verificar y revisar formulaciones, textos y medidas de etiquetado. - Preparar y tramitar registros de los productos finales. - Gestión de studios dermatologicos. Requisitos mínimos - Curso Experto en la Evaluación de la...
-
Regulatory Affairs
hace 1 semana
Tratamiento De Aguas (Goloso, El), España GSK A tiempo completoSite Name: GSK Tres Cantos, MadridPosted Date: Apr 5 2024Regulatory Affairs & Pack Management Trainee:Plan de formación propuesto:Aquellos jóvenes Farmacéuticos que busquen crecer en un entorno global e internacional y quieran desarrollar sus competencias encontrarán en estas prácticas una oportunidad única.Objetivos de formación: Conocer las...
-
Regulatory Affairs
hace 1 semana
Tratamiento De Aguas (Goloso, El), España GSK A tiempo completoSite Name: GSK Tres Cantos, MadridPosted Date: Feb Regulatory Affairs & Pack Management Trainee:Plan de formación propuesto:Aquellos jóvenes Farmacéuticos que busquen crecer en un entorno global e internacional y quieran desarrollar sus competencias encontrarán en estas prácticas una oportunidad única.Objetivos de formación: Conocer las actividades...
-
Alcalá de Henares, Madrid, España Synerlab Group A tiempo completoActividades destacadas a realizar:Medical Affairs:Colaboración en todas las actividades relacionadas con las partes clínicas y preclínicas del dossier de registro de medicamentos para productos actuales y potenciales, para registro y para contestar cartas de deficiencias y variaciones regulatorias en distintos territorios. También relacionadas con food...
-
Regulatory Solutions Consultant
hace 1 mes
El Prat de Llobregat, España Clarivate A tiempo completoWe are looking for a Regulatory Solutions Consultant to join our Clinical and Regulatory Team. This is an amazing opportunity to work on regulatory consulting projects. We have a great skill set in data monitoring, content writing and consulting for multiple domains- regulatory submissions, clinical trials, marketing authorization applications (MAA),...
-
Regulatory Solutions Consultant
hace 3 semanas
El Prat de Llobregat, España Clarivate A tiempo completoWe are looking for a Regulatory Solutions Consultant to join our Clinical and Regulatory Team. This is an amazing opportunity to work on regulatory consulting projects. We have a great skill set in data monitoring, content writing and consulting for multiple domains- regulatory submissions, clinical trials, marketing authorization applications (MAA),...
-
Asistente de Asuntos Regulatorios
hace 3 semanas
l'Hospitalet de Llobregat, España Synergie A tiempo completoRequisitos - Experiência mínima de un año en posiciones similares en gestión de calidad y gestión de normativas regulatorias. - Ingles fluido **Competencias/Habilidades**: Capacidad Analítica. Capacidad de Aprendizaje. Comunicación. Colaboración. Flexibilidad. Orientación Cliente. Iniciativa. Planificación. Orientación a...
-
Government Affairs Manager
hace 1 semana
Santiago de Compostela, La Coruña, España Corteva Agriscience A tiempo completoDescription At Corteva Agriscience, you'll help us grow what's next. No matter your role, you will be part of a team that is building the future of agriculture, solving the world's food problems through innovation, technology and putting people first. Today, there is an opportunity to join our Government & Industry Affairs team to manage the advocacy...
-
International Regulatory Affairs
hace 2 semanas
Azuqueca de Henares, España Morgan Philips Executive Search A tiempo completo**Global Responsability**: Support new regulatory submissions and assisting with the lifecycle management of the existing portfolio making sure that any variations and/or renewals will be submitted in time to ensure regulatory compliance. **Specific Responsibilities**: Support and provide the necessary documentation to local affiliates and clients for...
-
Alcalá de Henares, Madrid, España Synerlab Group A tiempo completoActividades destacadas a realizar:Medical Affairs:Colaboración en todas las actividades relacionadas con las partes clínicas y preclínicas del dossier de registro de medicamentos para productos actuales y potenciales, para registro y para contestar cartas de deficiencias y variaciones regulatorias en distintos territorios. También relacionadas con food...
-
Government Affairs Manager
hace 1 mes
Santiago de Compostela, España Corteva Agriscience A tiempo completoDescription At Corteva Agriscience, you’ll help us grow what’s next. No matter your role, you will be part of a team that is building the future of agriculture, solving the world’s food problems through innovation, technology and putting people first. Today, there is an opportunity to join our Government & Industry Affairs team to manage the...
-
Government Affairs Manager
hace 3 semanas
Santiago de Compostela, España Corteva Agriscience A tiempo completoDescription At Corteva Agriscience, you’ll help us grow what’s next. No matter your role, you will be part of a team that is building the future of agriculture, solving the world’s food problems through innovation, technology and putting people first. Today, there is an opportunity to join our Government & Industry Affairs team to manage the...
-
Assistant Regulatory Affairs and Patient Safety 1
hace 2 semanas
Sant Feliu de Llobregat, España Almirall A tiempo completoDate: May 15, 2024- City: SFEL - R&D SANT FELIU DE LLOBR**Mission**: Almirall is a global pharmaceutical company with 1,765 employees with direct presence in more than 20 countries. Almirall has consolidated international coverage on a global scale thanks to owned subsidiaries and sales agreements with the most prestigious partners in key markets such as the...
-
Regulatory & Product Compliance Expert
hace 1 mes
Cornellà de Llobregat, España Master Builders Solutions A tiempo completoJoin Us as a Regulatory Expert - Deputy for Head of Product Stewardship Are you passionate about ensuring the safety in chemical products? Do you thrive in a dynamic, international environment where compliance is paramount? If so, we have the perfect opportunity for you!About Us:At Master Builders Solutions, safety always comes first. We are a global leader...
-
Regulatory & Product Compliance Expert
hace 3 semanas
Cornellà de Llobregat, España Master Builders Solutions A tiempo completoJoin Us as a Regulatory Expert - Deputy for Head of Product Stewardship Are you passionate about ensuring the safety in chemical products? Do you thrive in a dynamic, international environment where compliance is paramount? If so, we have the perfect opportunity for you!About Us:At Master Builders Solutions, safety always comes first. We are a global leader...