Regulatory Affairs Strategist
hace 2 semanas
Aeros is seeking an experienced Regulatory Affairs Strategist to join our team. In this role, you will lead the development and execution of regulatory strategies to enable market access for our company in the Brain-Computer Interface (BCI) space.
About the Role:- Develop and execute global regulatory strategies to ensure compliance with relevant national and international regulations.
- Lead interactions with regulatory authorities, industry bodies, collaborative communities, and policymakers to shape the regulatory landscape for biotech.
- Analyze global regulatory policies and advise executive leadership on potential regulatory risks and opportunities.
- Minimum of 10 years of experience in medical technology regulation, with a strong background in neurotechnology and implantable devices (Class 2a and 2b or Class 3).
- Proven ability to interact effectively with US and international regulators, including the FDA.
- Experience with PMA processes, 510(k) submissions, and clinical trials.
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Regulatory Affairs Strategist
hace 1 semana
Buenos Aires, Buenos Aires C.F., Argentina Nbcuniversal A tiempo completoJob Description: In this exciting role as a Regulatory Affairs Specialist, you will lead and prepare Regulatory Affairs (RA) meetings involving cross-functional business partners. Your responsibilities may include reviewing submission dossiers, renewals, and responding to Government queries. You will also collaborate with the centre-led regulatory team on...
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Regulatory Affairs Coordinator
hace 5 días
Buenos Aires, Buenos Aires C.F., Argentina Unilever A tiempo completoRegulatory Affairs Coordinator OpportunityWe are seeking a highly organized and detail-oriented individual to join our team as a Regulatory Affairs Coordinator. This is a fantastic opportunity for someone who is passionate about regulatory affairs and wants to make a real difference.Key Accountabilities:Coordinate the preparation of regulatory compliance...
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Regulatory Affairs Director
hace 1 semana
Buenos Aires, Buenos Aires C.F., Argentina Medison Pharma A tiempo completoMedison Pharma - Regulatory Affairs Sr ManagerWe are seeking an experienced Regulatory Affairs Sr Manager to join our team in Medison Pharma. As a key member of our regulatory affairs team, you will play a critical role in ensuring compliance with local regulations and guidelines.ResponsibilitiesYour primary responsibilities will include:Developing and...
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Regulatory Affairs Professional
hace 7 días
Buenos Aires, Buenos Aires C.F., Argentina Medison Pharma A tiempo completoWe are seeking a highly experienced Regulatory Affairs Manager to lead our regulatory activities in Argentina, covering RA, PV, and QA areas. As a key member of our team, you will be responsible for developing, leading, and managing all regulatory activities, overseeing discussions and negotiations with local vendors and healthcare authorities, and...
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Regulatory Affairs Expert
hace 7 días
Buenos Aires, Buenos Aires C.F., Argentina Medison Pharma A tiempo completoAt Medison Pharma, we are a global pharmaceutical company dedicated to providing access to innovative therapies for patients worldwide. Our mission is to commercialize cutting-edge treatments across international markets, making a significant impact on the lives of those suffering from challenging diseases.Job DescriptionWe are seeking a highly skilled...
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Regulatory Affairs Director
hace 2 semanas
Buenos Aires, Buenos Aires C.F., Argentina Oppizi A tiempo completoAbout the RoleWe are seeking a highly skilled Regulatory Affairs Manager to join our team in Latin America. This is an exciting opportunity for a seasoned professional to lead our regulatory department and drive compliance across the region.The ideal candidate will have a strong background in food safety regulations, experience managing a team, and excellent...
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Regulatory Affairs Manager
hace 7 días
Buenos Aires, Buenos Aires C.F., Argentina Medison Pharma A tiempo completoMedison is a global pharma company providing access to highly innovative therapies to patients in international markets. Medison commercializes highly innovative therapies across international markets, helping to save and improve the lives of patients suffering from the most challenging diseases.Medison is rapidly growing in the international markets backed...
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Regulatory Affairs Specialist
hace 2 semanas
Buenos Aires, Buenos Aires C.F., Argentina Alimentiv A tiempo completoAs a key member of Alimentiv's team, you will be responsible for providing high-quality Global Regulatory Affairs support services.Key Responsibilities:Clinical Trial Applications: Manage the submission of clinical trial applications to Competent Authorities, Ethics Committees, and Regulatory Agencies.Regulatory Research: Conduct research and review global...
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Regulatory Affairs Specialist
hace 2 semanas
Buenos Aires, Buenos Aires C.F., Argentina Alimentiv A tiempo completoResponsible for the day-to-day activities and delivery of Global Regulatory Affairs support services. Role will include management of clinical trial applications to Competent Authorities, Ethics Committees and Regulatory Agencies, and the research, review and reporting on applicable global regulations and requirements. Develop stakeholder tools,...
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Regulatory Affairs Specialist
hace 4 horas
Buenos Aires, Buenos Aires C.F., Argentina beBee Careers A tiempo completoAbout the RoleAs a Regulatory Affairs Analyst, you will be responsible for preparing and elaborating dossiers to comply with regional strategic plans and maintaining marketing authorizations for products on the market.Main Responsibilities:To undertake all necessary dossier preparation, evaluation, and timely submission in accordance with local regulations,...
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Regulatory Affairs Expert
hace 2 semanas
Buenos Aires, Buenos Aires C.F., Argentina NBCUniversal A tiempo completoCompany Overview">At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.We want to accelerate and advance our ability to create meaningful...
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Country Regulatory Affairs Manager
hace 4 días
Buenos Aires, Buenos Aires C.F., Argentina Nec Argentina A tiempo completoWe are looking for a motivated Country Regulatory Affairs Manager to oversee local regulatory strategy and ensure compliance with MoH and EC regulations.As a key contact at the country level, you will provide project-specific services, coordinate submissions, and work closely with investigators and internal departments to achieve PPD's target cycle times for...
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Regulatory Affairs Specialist
hace 1 semana
Buenos Aires, Buenos Aires C.F., Argentina Nbcuniversal A tiempo completoCareers that Change Lives In this exciting role as a Regulatory Affairs Specialist, you will lead and prepare Regulatory Affairs (RA) meetings (regulatory status) involving cross-functional business partners under your responsibility.To provide status on time about projects and all applicable regulatory activities assigned per Senior Supervisor or RA...
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Regulatory Affairs Sr Manager
hace 1 semana
Buenos Aires, Buenos Aires C.F., Argentina Medison Pharma A tiempo completoMedison is a global pharma company providing access to highly innovative therapies to patients in international markets. Medison commercializes highly innovative therapies across international markets, helping to save and improve the lives of patients suffering from the most challenging diseases.Medison is rapidly growing in the international markets backed...
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Senior Scientist, Regulatory Affairs, Latam
hace 2 semanas
Buenos Aires, Buenos Aires C.F., Argentina Dana Tm4 A tiempo completoSenior Scientist, Regulatory Affairs, LatamSeqirusPlease present resumes in English.The Opportunity You will be a technical specialist within the LATAM Region and will have the opportunity to shape the vision and goals for Global Regulatory Affairs and Seqirus by providing specialist, regional advice and support.You will partner with other functions in...
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Regulatory Affairs Specialist
hace 2 semanas
Buenos Aires, Buenos Aires C.F., Argentina NBCUniversal A tiempo completoCareers that Change LivesIn this exciting role as a Regulatory Affairs Specialist, you will lead and prepare Regulatory Affairs (RA) meetings (regulatory status) involving cross-functional business partners under your responsibility. To provide status on time about projects and all applicable regulatory activities assigned per Senior Supervisor or RA...
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Regulatory Affairs Specialist II
hace 7 días
Buenos Aires, Buenos Aires C.F., Argentina Boston Scientific A tiempo completoCompany OverviewBoston Scientific is a leader in medical science with over 40 years of experience. We are committed to solving the challenges that matter most – united by a deep caring for human life.Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our...
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Regulatory Affairs Senior Manager
hace 1 semana
Buenos Aires, Buenos Aires C.F., Argentina Medison Pharma A tiempo completoJob DescriptionMedison Pharma is a global pharmaceutical company that provides innovative therapies to patients worldwide. Our mission is to improve and save lives by commercializing highly innovative treatments across international markets.ResponsibilitiesThe Regulatory Affairs Sr Manager will be responsible for all regulatory activities in Argentina,...
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Regulatory Affairs Senior Associate
hace 5 días
Buenos Aires, Buenos Aires C.F., Argentina Web: A tiempo completoSenior Associate Regulatory Affairs OverviewWe are seeking a highly skilled Senior Associate Regulatory Affairs professional to join our team at Amgen.About the Role:The Senior Associate Regulatory Affairs will be responsible for ensuring life-cycle management for local products and production as local regulatory for selected products (biologics and...
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Senior Scientist, Regulatory Affairs, Latam
hace 3 semanas
Buenos Aires, Buenos Aires C.F., Argentina Dana TM4 A tiempo completoSenior Scientist, Regulatory Affairs, LatamSeqirusPlease present resumes in English.The OpportunityYou will be a technical specialist within the LATAM Region and will have the opportunity to shape the vision and goals for Global Regulatory Affairs and Seqirus by providing specialist, regional advice and support. You will partner with other functions in...