Regulatory Affairs Manager
5 days ago
This is a rare opportunity to join TN Ireland, a clinical-stage biotechnology company focused on discovering and developing novel therapies for debilitating diseases. The company has experienced rapid growth in 2023.
Job Overview:The Senior Director Regulatory Affairs Device will lead key elements of regulatory systems, ensuring compliance with relevant standards for medical devices including ISO 13485 and FDA QSR. This role involves defining the device regulatory strategy and overseeing all device submissions across global markets.
Key Responsibilities:- Define the global regulatory strategy for medical device products in partnership with cross-functional teams.
- Plan, submit and maintain technical files and regulatory dossiers for clinical trial and marketing applications.
- Lead planning and execution of regulatory agency meetings/communications and scientific advice processes.
- Manage CE Marking of medical devices, including notified body selection, QMS audits and technical file compilation and audit.
- Bachelors or Graduate degree qualification in Science, Engineering or related field.
- 10+ years experience in medical device/combination product development and regulatory affairs.
- Proven experience with small molecule/biologic drug development in the context of drug/device combination products.
- Knowledge of EU MDR 2017/745, ISO 13485, 21 CFR Part 820, and FDA QSRs required.
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Regulatory Affairs Manager
2 days ago
Dublin, Dublin City, Ireland Wallace Myers International Full timeJob DescriptionWe are seeking a highly skilled Regulatory Affairs Manager to join our Asset Management team. As a key member of our regulatory affairs department, you will be responsible for ensuring our company remains compliant with all relevant regulatory requirements.Main ResponsibilitiesMonitoring and reporting on regulatory changes and their impact on...
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Regulatory Affairs Manager
3 weeks ago
Dublin, Dublin City, Ireland Cpl Healthcare Full timeRegulatory Affairs ManagerMy client, a multinational medical device and health care company, is looking to recruit a Regulatory Affairs Manager. The Regulatory Affairs Manager will be in charge of managing teams within the Regulatory Affairs Sub-Function. The core focus of this position is on policy and strategy implementation and control rather than...
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Regulatory Affairs Manager
6 days ago
Dublin, Dublin City, Ireland Robert Walters Ireland Full timeWe are excited to be working with a global leading Investment firm in Dublin who are looking for a Regulatory Affairs Manager to join the business. This role offers a unique opportunity to shape the firm's regulatory policies and ensure compliance across multiple jurisdictions.As a Regulatory Affairs Manager, you will conduct horizon scanning for regulatory...
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Regulatory Affairs Specialist
4 days ago
Dublin, Dublin City, Ireland CPL Full timeThornshaw Scientific, a division of the CPL Group, is seeking an experienced Regulatory Affairs Specialist to join our Dublin team. As a key member of our regulatory affairs team, you will be responsible for managing EU marketing authorisation dossiers and submissions, preparing and filing EU submissions, and writing local modules and administrative...
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Regulatory Affairs Manager
4 days ago
Dublin, Dublin City, Ireland TN Ireland Full timeJob DescriptionWe are seeking an experienced Regulatory Affairs Manager to join our team at TN Ireland. The successful candidate will be responsible for providing support to interpret the current, approved and planned clinical regulatory landscape.About the Role:Contribute to the management of the regulatory submission form process, involving review of...
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Regulatory Affairs Director
9 hours ago
Dublin, Dublin City, Ireland Cpl Healthcare Full timeJob Description:Cpl Healthcare on behalf of their client, a global pharmaceutical company, is seeking a highly skilled Regulatory Affairs Manager to join their team in Dublin.This full-time/hybrid position reports to the Global Regulatory Affairs Associate Director and involves taking a lead role and responsibility for planning, executing, tracking, and...
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Regulatory Affairs Manager
13 hours ago
Dublin, Dublin City, Ireland Cpl Healthcare Full timeJOB DESCRIPTION FORM Thornshaw Scientific on behalf of their client, a global pharmaceutical company now have a new opportunity for a Regulatory Affairs Manager to join the team in Dublin. Reporting to the Global Regulatory Affairs Associate Director, this is a full time/hybrid position.The role & Responsibilities: To take lead role and responsibility for...
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Regulatory Affairs Manager
3 weeks ago
Dublin, Dublin City, Ireland GxP Recruitment Full timeIn this role you will be in charge of managing teams within the Regulatory Affairs Sub-Function.Focus is on policy and strategy implementation and control rather than development and you will typically handle short-term operational/tactical responsibilities.As the Manager of the Regulatory Affairs Sub-Function, you will be responsible to:Oversee the strategy...
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Regulatory Affairs Consultant
2 days ago
Dublin, Dublin City, Ireland IQVIA LLC Full timeRegulatory Affairs Consultant page is loadedRegulatory Affairs ConsultantApply locations Dublin, Ireland Roscommon, Connaught, Ireland time type Part time posted on Posted Yesterday job requisition id R1475082Join Our Team: Regulatory Affairs ConsultantAre you a skilled Regulatory Affairs professional with strong technical knowledge and experience in the...
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Regulatory Affairs Consultant
1 day ago
Dublin, Dublin City, Ireland IQVIA Full timeIQVIA Regulatory Affairs Consultant in Dublin, IrelandJoin Our Team: Regulatory Affairs ConsultantAre you a skilled Regulatory Affairs professional with strong technical knowledge and experience in the pharmaceutical industry? We are seeking an exceptional Regulatory Affairs Consultant to support our client's growing portfolio of niche, value-added products...
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Regulatory Affairs Officer
6 days ago
Dublin, Dublin City, Ireland Cpl Full timeRegulatory Affairs Officer & Senior Regulatory Affairs OfficerThornshaw Scientific, in collaboration with my client, a global pharmaceutical company, now have a new opportunity for a Regulatory Affairs Officer to join the Dublin team. The same company also have Senior Regulatory Affairs Officer opportunities.Key Responsibilities:Manage EU marketing...
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Regulatory Affairs Specialist
5 days ago
Dublin, Dublin City, Ireland Cpl Full timeJob Title: Regulatory Affairs SpecialistAbout the Role:We are seeking a highly skilled Regulatory Affairs Specialist to join our team in Dublin. As a Regulatory Affairs Specialist, you will be responsible for managing EU marketing authorisation dossiers and submissions, preparing and filing EU submissions, and writing local modules and administrative...
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Regulatory Affairs Technical Manager
4 weeks ago
Dublin, Dublin City, Ireland RedChair Recruitment Full timeWhat we are looking for: You will ensure that the requirements of the industry and regulatory bodies are fulfilled. You will be Responsible for the communications and interactions with the Competent Authorities in relation to the Authorized Representative duties. You will contribute to Regulatory Affairs activities across the company, ensuring...
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Regulatory Affairs Manager
3 weeks ago
Dublin, Dublin City, Ireland Thornshaw Recruitment Full timeThornshaw Scientific on behalf of their client, a global pharmaceutical company now have a new opportunity for a Regulatory Affairs Manager to join the team in Dublin.Reporting to the Global Regulatory Affairs Associate Director, this is a full time/hybrid position.The role & Responsibilities:To take lead role and responsibility for the effective planning,...
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Regulatory Affairs Specialist
4 days ago
Dublin, Dublin City, Ireland Novartis Farmacéutica Full timeJob SummaryWe are seeking a talented Regulatory Affairs Specialist to join our team as a key member of our Central Integrated Scientific Review Committee Lead function. The successful candidate will have a strong background in regulatory affairs, with experience in managing the review process for clinical documents across therapeutic areas in Development.As...
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Regulatory Affairs
3 weeks ago
Dublin, Dublin City, Ireland Thornshaw Recruitment Full timeThornshaw Scientific, in collaboration with my client, a global pharmaceutical company, now have a new opportunity for a Regulatory Affairs Officer to join the Dublin team.Key Responsibilities:Manage EU marketing authorisation dossiers and submissions (MAAs, lifecycle activities, variations, transfer etc.) for our current portfolio of pharmaceutical...
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Regulatory Affairs Manager
3 weeks ago
Dublin, Dublin City, Ireland Thornshaw Recruitment Full timeThornshaw Scientific on behalf of their client, a global pharmaceutical company now have a new opportunity for a Regulatory Affairs Manager to join the team in Dublin.Reporting to the Global Regulatory Affairs Associate Director, this is a full time/hybrid position.The role & Responsibilities:To take lead role and responsibility for the effective planning,...
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Regulatory Affairs Manager
2 days ago
Dublin, Dublin City, Ireland Cpl Healthcare Full timeJOB DESCRIPTION FORMThornshaw Scientific on behalf of their client, a global pharmaceutical company now have a new opportunity for a Regulatory Affairs Manager to join the team in Dublin.Reporting to the Global Regulatory Affairs Associate Director, this is a full time/hybrid position.The role & Responsibilities:To take lead role and responsibility for the...
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Regulatory Affairs Manager
11 hours ago
Dublin, Dublin City, Ireland Cpl Healthcare Full timeJOB DESCRIPTION FORMThornshaw Scientific on behalf of their client, a global pharmaceutical company now have a new opportunity for a Regulatory Affairs Manager to join the team in Dublin.Reporting to the Global Regulatory Affairs Associate Director, this is a full time/hybrid position.The role & Responsibilities:Take lead role and responsibility for the...
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Regulatory Affairs Manager
3 weeks ago
Dublin, Dublin City, Ireland Parexel Full timeWhen our values align, there's no limit to what we can achieve. Are you an experienced regulatory professional looking for a new opportunity? We are currently seeking a talented CMC Regulatory Manager (Regulatory Affairs Consultant) to join our dynamic team This is a client dedicated project, and the role can be office or home based in various...