Associate Director, Regulatory Affairs
hace 1 mes
.Job Title: Associate Director, Regulatory Affairs - Medical Device/Post-Market Surveillance Job Type: Full Time, Permanent Position Location: Spain, Madrid – Hybrid Remuneration: Attractive salary and package An exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology. Due to increasing growth, the business is looking for an Associate Director, Regulatory Affairs Medical Device Lifecycle Management to join the team. As an Associate Director, Regulatory Affairs - Medical Devices Lifecycle Management, you will be responsible for the strategic lifecycle management of the business's Medical Device post CE approval and the operational execution management with the Regulatory Service Provider. This includes the responsibility and oversight of all activities required for the successful and smooth integration of new products following launch and all associated ongoing regulatory maintenance activities. Main Responsibilities: Be the primary regulatory point of contact for all medical device queries for the business's portfolio by providing guidance on regulatory medical device requirements and compliance to brand teams and other areas of the business. Input into discussions on projects and questions associated with medical devices, anticipating and resolving complex regulatory issues. Lead and support all post-market surveillance activities for the medical device portfolio in the UK, Europe, and growth regions. Drive all Regulatory Affairs Medical Device strategies for global regions. Oversee, manage, and advise the Regulatory Service Provider on medical device maintenance and submission strategies, plans, and preparation of updates to the technical file and regulatory submissions for all medical device-related changes. Prepare high-quality documentation for labeling regulatory submissions, following current best practices. Represent Regulatory Affairs Lifecycle Management – Medical Devices internally and externally. Maintain up-to-date knowledge of relevant regulations, guidelines, and industry standards and apply in practice through procedures, knowledge sharing, and advice to project teams. Manage regulatory intelligence information for medical devices including databases (e.G., NOTIS). Coordinate QMS-related regulatory activities e.G., deviations and CAPAs as applicable. Manage own workload, including responsible delegation, to ensure agreed regulatory activities are planned, agreed, and progressed. Requirements: BS, BSc, MS, MSc, PhD, PharmD, J.D., M.D. in science or healthcare preferred or equivalent relevant experience. Previous experience in Regulatory Affairs is a MUST At least 8 years + experience within the medical device sector with a sound understanding of new registrations and post-market surveillance activities. Confident with maintaining medical devices in global regions
-
Senior Regulatory Affairs Manager
hace 1 mes
Zaragoza, Zaragoza, España Cpl Healthcare A tiempo completoJob Title:Senior Regulatory Affairs Manager - Medical Device/Post-Job Summary:Cpl Healthcare is seeking a Senior Regulatory Affairs Manager to join our team in Spain, Madrid. As a Senior Regulatory Affairs Manager, you will be responsible for the strategic lifecycle management of our medical device portfolio, including post-CE approval and operational...
-
Junior Manager Regulatory Affairs Cmc
hace 2 meses
Zaragoza, España Mabxience A tiempo completo.Overview:The Junior Manager, Regulatory Affairs CMC is responsible to provide regulatory relevant technical assistance to development teams and ensures adequacy of CMC documentation for global regulatory submissions including specific requirements for regional registration processes.The position supports and promotes all regulatory CMC tasks throughout the...
-
Regulatory Affairs Expert
hace 1 mes
Zaragoza, Zaragoza, España British American Tobacco A tiempo completoBritish American Tobacco is a global leader in the tobacco industry, and we're now evolving at an accelerated pace into a multi-category business.To achieve our ambition of decreasing the health impact of our industry, we're looking for experts who can help us navigate the complex regulatory landscape.The successful candidate will report directly to the...
-
Energy Sourcing
hace 4 semanas
Zaragoza, España Essity A tiempo completoEnergy Sourcing & Regulatory Affairs Manager - Spain About the Role This position supports the strategy for Energy procurement in Spain by sourcing energy for high-consumption sites within the framework of the global energy risk policy. You will manage regulatory issues related to energy consumption in Spain, ensuring compliance and competitiveness. We're...
-
Regulatory Affairs Manager Labeling + Submissions
hace 7 meses
Zaragoza, España Pharmalex A tiempo completo**We are growing, grow with us!** Cencora PharmaLex is one of the leading service providers for the global pharmaceutical industry. We offer end-to-end regulated services and specialize in all aspects of approval and maintenance of medicinal products and medical devices. We support pharma companies throughout the entire product lifecycle, ensuring initial...
-
Head of Corporate and Regulatory Affairs
hace 2 meses
Zaragoza, Zaragoza, España British American Tobacco A tiempo completoTransforming the Future of BATBritish American Tobacco is undergoing a significant transformation, shifting from a traditional tobacco company to a global multi-category business. As we continue to evolve, we are seeking a highly skilled Head of Corporate and Regulatory Affairs to join our team in Madrid, Spain.The successful candidate will be responsible...
-
Medical Director, Rheumatology
hace 2 meses
Zaragoza, España Icon Plc A tiempo completo.Medical Director, Rheumatology ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Rheumatologist to join our diverse and...
-
Policy&Government Affairs Sr Manager
hace 2 meses
Zaragoza, España Bristol-Myers Squibb A tiempo completo.Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...
-
Principal Biostatistician
hace 2 meses
Zaragoza, España Syneos Health, Inc. A tiempo completo.Principal Biostatistician (Medical Affairs Required)Updated: October 1, 2024Location: Spain-Europe - ESP-Home-Based (Madrid)Job ID:24005267Remote Principal Biostatistician - Must be in NA or EMEA (Prior Medical Affairs experience is required)Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer...
-
Cost Improvement Strategist
hace 3 semanas
Zaragoza, Zaragoza, España Bd A tiempo completoJob Overview:The Associate Director, ISC Cost to Win Leader IS/CC is a critical member of the IS/CC Platform team, reporting to the Sr Director, ISC CTW Cost Improvement. This role will drive Cost Improvement strategies in support of the platform's strategic product cost and GP goals, working closely with Procurement, BD Excellence, Supply Chain, Quality,...
-
Regulatory Technology Specialist
hace 3 semanas
Zaragoza, Zaragoza, España Tether Operations Limited A tiempo completo{"h2":"Compliance Technology Initiatives Leader"}Tether Operations Limited is seeking a seasoned Head of RegTech to spearhead our compliance technology initiatives. As a key member of our team, you will collaborate with company executives and stakeholders to develop and implement a comprehensive strategy for investigations and analysis.About the RoleIn this...
-
Director Global Pharmacovigilance
hace 2 meses
Zaragoza, España Teva A tiempo completoDirector Global Pharmacovigilance - Safety PhysicianLead the safety profile of the assigned product(s) during clinical development including Company Sponsored studies, Investigator Sponsored studies, Compassionate Use and Disease Monitoring Programs. Collaborate with other R&D teams to ensure execution of the safety strategy.Contribute to clinical documents,...
-
Sr. Compliance Associate With German
hace 2 meses
Zaragoza, España Amazon A tiempo completoCompliance Associate with German, Global Solutions & Risk Compliance (GSRC)The Global Solutions and Risk Compliance (GSRC) team ensures that Amazon transactions satisfy legal and safety requirements in accordance to the guidelines across global marketplaces. We proactively identify risks involved for Amazon while doing business in various countries and...
-
Principal Biostatistician
hace 1 mes
Zaragoza, España Syneos Health Healthcare Careers A tiempo completo.Principal Biostatistician (Medical Affairs Required)Syneos Health Healthcare Careers – Madrid, MadridRemote Principal Biostatistician - Must be in NA or EMEA (Prior Medical Affairs experience is required)Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical,...
-
Associate Epidemiology Director
hace 4 meses
Zaragoza, España Iqvia A tiempo completo.Associate Epidemiology DirectorIQVIA Real World SolutionsHome-Based / Hybrid / Office-BasedJoin us on our exciting journey!This innovative epidemiologist role sits in the Center for Advanced Evidence Generation (CAEG) at IQVIA and reports directly to the Chief Scientific Officer.CAEG works alongside scientific teams across IQVIA and is responsible for...
-
Talent Management Associate Director
hace 4 semanas
Zaragoza, España Wolters Kluwer A tiempo completo.Wolters Kluwer is a global leader in information services and solutions for professionals in the finance, tax and accounting, risk and compliance, health and legal sectors. We help our customers make critical decisions every day by providing expert solutions that combine deep domain knowledge with specialized technology and services. We are currently...
-
Junior Associate Counsel
hace 2 meses
Zaragoza, España California Museum-Photography A tiempo completoAs Junior Associate Counsel, you will be providing legal support across all areas of a fast-paced and dynamic business and playing a key role in the legal team. The role includes but is not limited to administrating, reviewing, and drafting legal agreements. As Skydance continues its growth, the Junior Associate Counsel will have the opportunity to work on a...
-
Director/A De Arte
hace 2 meses
Zaragoza, España Llyc A tiempo completo.LLYC es una firma global de Corporate Affairs y Marketing, que trabaja como partner de sus clientes en materia de creatividad, influencia e innovación, con el objetivo de hacer crecer y proteger el valor de sus negocios, convirtiendo cada día en una oportunidad para nutrir sus marcas.En CHINA - parte de LLYC, buscamos un/a Director/a de Arte con al menos...
-
Medical Director- Oncology/Hematology
hace 4 meses
Zaragoza, España Iqvia A tiempo completo.Job OverviewThe medical department consists of a Chief Medical Officer, Medical Directors, medical writers, and safety associates. The Medical Director provides medical and scientific support to clinical research programs, study teams, and investigators.The Medical Director also provides review, advice, and leadership for potentially or awarded clinical...
-
Associate Director Insights
hace 2 meses
Zaragoza, España Regeneron Pharmaceuticals, Inc A tiempo completo.The Associate Director Insights & Analytics (Oncology International) will provide strategic expertise to help optimize business performance and enable informed decision making. The role will report directly to the Director, Insights & Analytics (Oncology International). In addition, this role will oversee International Oncology performance analytics, as...