Associate Director, Regulatory Affairs
hace 2 días
.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
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Regulatory Affairs Director
hace 7 días
Zaragoza, Zaragoza, España Cpl Healthcare A tiempo completoJob Title: Associate Director, Regulatory Affairs Medical Devices Lifecycle ManagementJob Type: Full Time, Permanent PositionLocations: Spain, Madrid – HybridRemuneration: Attractive salary and packageCpl Healthcare is seeking an experienced Associate Director, Regulatory Affairs Medical Devices Lifecycle Management to join our team. As a key member of our...
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Regulatory Affairs Director
hace 2 semanas
Zaragoza, Zaragoza, España Cpl Healthcare A tiempo completoJob Title: Associate Director, Regulatory Affairs - Medical Device/Post-Market SurveillanceJob Type: Full Time, Permanent PositionLocations: Spain, Madrid – HybridRemuneration: Attractive salary and packageAn exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology and Hepatology. Due to...
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Associate Director Medical Affairs
hace 2 meses
Zaragoza, España Regeneron Pharmaceuticals A tiempo completoAs an Associate Director Medical Affairs, you will play a pivotal role between Regeneron and the scientific and healthcare community, supporting the Oncology portfolio.We use our expertise provisioning business objectives across the product life cycle.We deliver strategic and operational support by establishing, developing, and maintaining exchanges with...
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Regulatory Affairs Manager
hace 2 semanas
Zaragoza, Zaragoza, España Montezuma Winery Llc A tiempo completoJob SummaryWe are seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our regulatory team, you will be responsible for managing the preparation and revision of labeling and regulatory submissions for our pharmaceutical products.Key Responsibilities:Manage the creation and maintenance of labeling and regulatory...
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Regulatory Affairs Specialist
hace 1 semana
Zaragoza, Zaragoza, España Kenvue A tiempo completoRegulatory Affairs Internship OpportunityKenvue, a leading healthcare company, is seeking a highly motivated and detail-oriented Regulatory Affairs Intern to join our team. As a Regulatory Affairs Intern, you will play a critical role in ensuring the compliance of our products with regulatory requirements.Key Responsibilities:Coordinate and compile new drug...
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Senior Regulatory Affairs Manager
hace 2 días
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...
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Regulatory Affairs Specialist
hace 1 semana
Zaragoza, Zaragoza, España Kenvue A tiempo completoRegulatory Affairs InternAt Kenvue, we're committed to delivering the best products to our customers. As a Regulatory Affairs intern, you will play a key role in ensuring compliance with regulatory requirements for our products in Spain. Your responsibilities will include coordinating and submitting new drug applications, cosmetics, medical devices, and food...
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Regulatory Affairs Manager
hace 2 semanas
Zaragoza, Zaragoza, España Montezuma Winery Llc A tiempo completoRegulatory Affairs ManagerWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Montezuma Winery Llc. As a key member of our regulatory team, you will be responsible for ensuring compliance with global pharmaceutical regulations and managing the creation and maintenance of labelling documentation.Key Responsibilities:Participate in...
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Regulatory Affairs Specialist |
hace 1 mes
Zaragoza, España Zentiva Group, A.S. A tiempo completo.MissionThe Regulatory Affairs Specialist at local / country level is accountable for managing the Regulatory Affairs agenda at country level within Zentiva. This will include:Provide an efficient and proactive Regulatory service to meet the business objectives.Support proactively commercialisation of products.Ensure agility in daily interaction with...
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Regulatory Affairs Specialist
hace 7 días
Zaragoza, Zaragoza, España Kenvue A tiempo completoAbout the RoleKenvue is a global company with a rich heritage and a passion for science. We're the house of iconic brands, including Neutrogena, Aveeno, Tylenol, Listerine, Johnson's, and BAND-AID Brand Adhesive Bandages. Our global team is made up of ~22,000 diverse and brilliant people, passionate about insights, innovation, and committed to delivering the...
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Regulatory Affairs Manager CMC
hace 2 semanas
Zaragoza, Zaragoza, España Mabxience A tiempo completoJob SummaryThe Junior Manager, Regulatory Affairs CMC is responsible for providing regulatory technical assistance to development teams and ensuring the adequacy of CMC documentation for global regulatory submissions. This includes specific requirements for regional registration processes. The position supports and promotes all regulatory CMC tasks...
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Regulatory Affairs Specialist
hace 7 días
Zaragoza, Zaragoza, España Montezuma Winery Llc A tiempo completoJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Montezuma Winery Llc. This is a challenging opportunity for a professional with experience in labeling activities for innovator drugs on a global level.Key ResponsibilitiesParticipate in the preparation and revision of informative texts for healthcare professionals...
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Head of Corporate and Regulatory Affairs
hace 2 semanas
Zaragoza, Zaragoza, España British American Tobacco A tiempo completoJob SummaryBritish American Tobacco is seeking a seasoned professional to lead our Corporate and Regulatory Affairs team in Iberia. As Head of Corporate and Regulatory Affairs, you will be responsible for developing and implementing strategies to ensure the regulatory approach by governments to issues that affect our business operations.Key Responsibilities...
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Regulatory Affairs Specialist
hace 2 semanas
Zaragoza, Zaragoza, España Ramboll Group AS A tiempo completoKey Responsibilities:We are seeking a highly skilled Regulatory Affairs Specialist to provide technical support to clients and colleagues on issues relating to product regulatory compliance and stewardship in Spain.The ideal candidate will have a strong understanding of European regulations governing product safety and stewardship, as well as excellent...
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Head of Corporate and Regulatory Affairs
hace 3 semanas
Zaragoza, Zaragoza, España British American Tobacco A tiempo completoHead of Corporate and Regulatory AffairsBritish American Tobacco is seeking a seasoned professional to lead our corporate and regulatory affairs efforts in Iberia. As a key member of our team, you will develop and implement strategies to ensure the company's regulatory approach is aligned with our business objectives.Key Responsibilities:Develop and execute...
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Head of Corporate and Regulatory Affairs
hace 3 semanas
Zaragoza, Zaragoza, España British American Tobacco A tiempo completoHead of Corporate and Regulatory AffairsBritish American Tobacco is seeking a seasoned professional to lead our corporate and regulatory affairs efforts in Iberia. As a key member of our team, you will develop and implement strategies to ensure the company's regulatory approach is aligned with our business objectives.Key Responsibilities:Develop and execute...
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Head Of Corporate
hace 1 mes
Zaragoza, España The British American Tobacco Group A tiempo completo.BAT is evolving at pace into a global multi-category business. With products like VELO, VUSE and GLO we are on a mission to decrease the health impact of our industry.To achieve our ambition, we are looking for colleagues who are ready to Be The Change. Come, join us on this journey!BAT IBERIA has an exciting opportunity for a HEAD OF CORPORATE & REGULATORY...
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Regulatory Affairs Manager CMC
hace 7 días
Zaragoza, Zaragoza, España Mabxience A tiempo completoJob Summary:The Junior Manager, Regulatory Affairs CMC is responsible for providing regulatory relevant technical assistance to development teams and ensuring the adequacy of CMC documentation for global regulatory submissions, including specific requirements for regional registration processes. This position supports and promotes all regulatory CMC tasks...
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Junior Manager Regulatory Affairs Cmc
hace 2 semanas
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...
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Regulatory Affairs Specialist
hace 7 días
Zaragoza, Zaragoza, España Montezuma Winery Llc A tiempo completoJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Montezuma Winery Llc. As a key member of our regulatory team, you will be responsible for ensuring compliance with global pharmaceutical regulations and managing the creation and maintenance of labelling documentation.Key ResponsibilitiesParticipate in the...