Regulatory Affairs Senior Specialist EMEA M/F
hace 2 semanas
Select how often (in days) to receive an alert:Regulatory Affairs Senior Specialist EMEA M/FJob Function: RegulatoryLocation: Cornella de Llobregat, B, ESWe are ZimVie, a publicly traded, global life sciences leader focused on restoring daily life to our patients by designing, manufacturing, and distributing a comprehensive portfolio of innovative tooth replacement and spine surgery solutions. Our company is founded on a legacy of trusted brands, products, and clinical evidence made possible through an inclusive and collaborative culture that empowers our team members to bring their whole selves – their best selves – to work every day to accomplish our Mission. Together, our dedicated, diverse global team is shaping an exciting future, and we hope you’ll consider being a part of itAbout the role:Lead and prepare technical documentation, including biocompatibility, clinical, and post-market surveillance reports. Assist the Global Regulatory Affairs Manager with topics related to clinical affairs, regulatory compliance, and regulatory affairs.What you’ll be doing:Prepare CERs for the Technical DocumentationsPrepare post-market surveillance reportsPrepare biocompatibility reportsMaintain and prepare Technical Documentations according to EU MDR requirementsReview new regulatory requirements and implement them accordinglySupport QMS maintenance including alignment with QMS of ZimVieSupport R&D in the development of new productsPrepare and submit 510(k)Participate in External and Internal auditsWhat you’ll need:University degree in a Science related subject (e.g., Biology, Biotechnology, Pharmacy, etc.)5 years’ experience in a similar positionSME in ISO 10993, ISO 14155, ISO 13485, EU MDR implementation, FDA 21 CFR 820 and submission of 510(k)Communications and organizational skillsFluent in English. Other European languages is a plusInitiative, flexibility and team playerPossibility to travel to Spain, Italy and GermanyWhat we offer:Working in a diverse and collaborative global team embracing innovative curiosity, personal authenticity, accountability, and a growth mindset. Our culture empowers us to bring our whole selves to work each day, so we can be at our best when serving our customers, patients, and colleagues.ZimVie offers you a challenging position with good career prospects in an international medical device business and following benefits:Competitive compensation packagePermanent contractPartially remote work option availablePrivate life, health and dental insuranceDo you want to know more about us? Click HERE to watch our story.ZimVie is an Equal Opportunity Employer committed to diversity and inclusion in the workplace. All qualified applicants for employment and employment decisions, including hiring, promotion, transfer, etc. are considered without regard to racial or ethnic origin, gender, religion or belief, disability, age or sexual identity.
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Regulatory Affairs Associate
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España buscojobs España A tiempo completoRegulatory Affairs AssociateBarcelona, CataloniaGalderma - 28.11.2024With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative approach to dermatological care.Regulatory Affairs AssociateBarcelona, CataloniaGlobal...
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Senior Regulatory Affairs Specialist
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Chemical Regulatory Affairs Associate
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Senior Regulatory Affairs Specialist
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España Grifols, S.A A tiempo completoWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and...
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Senior Regulatory Affairs Specialist
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España Grifols A tiempo completoWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and...
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Senior Regulatory Affairs Specialist
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Senior Director of Clinical Affairs, EMEA RM
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Regulatory Affairs Specialist
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Regulatory Affairs Specialist
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España Michael Page A tiempo completoMultinational Company | Career development opportunityMultinational company specialized in health supplements and bio ingredients.Reporting to the Regulatory Affairs Director, the Regulatory Affairs Specialist will be primarily responsible for:The preparation, submission, monitoring, and updating of regulatory dossiers.Preparing high-quality regulatory...
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España buscojobs España A tiempo completoAt AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional...
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España AstraZeneca GmbH A tiempo completoAt AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional...
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Regulatory Affairs Manager
hace 4 semanas
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Regulatory Affairs Associate
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España Galderma Pharma S.A A tiempo completoRegulatory Affairs Associate With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology...
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Regulatory Affairs Specialist
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España Arxada A tiempo completoArxada is a global leader in specialty chemicals, committed to solving the world's toughest preservation challenges through innovative science. With a legacy of over a century, we strive to develop sustainable solutions that enhance the health and wellbeing of people, extend the life of vital infrastructure, and reduce ecological footprints. Sustainable...
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Associate Director, Regulatory Affairs
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hace 3 semanas
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Regulatory Affairs Junior
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España Page Personnel España A tiempo completoTécnico/a para la preparación de la documentación regulatoria de los productos desarrollados por la empresa, complementos alimenticios, productos sanitarios clase IIa, productos sanitarios in vitro y cosméticos. Formación en Ciencias de la Salud|Prácticas en RA y/o Máster en Registros - Formación en Ciencias de la Salud: Farmacia, biología,...