Regulatory Affairs Specialist
7 days ago
Regulatory Affairs Specialist Excellent opportunity for a Senior Regulatory Affairs Specialist to join a thriving company in Co. Clare. The Senior Regulatory Affairs Specialist will be responsible for developing and implementing regulatory strategies to support the timely and successful registration, approval, and maintenance of company and client products. The Senior Regulatory Affairs Specialist will also provide support to the functional project teams on Biological Evaluations for new and existing products/indications and will be responsible for implementing biological evaluation plans. Key Responsibilities: Lead the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products. Respond to requests from notified bodies; competent authorities and/ or distributors to prepare and submit documentation for marketing approval as well as provide routine regulatory information Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required. Provide regulatory direction to development project teams as a core team member. Advise other functional units (engineering, marketing, operations, quality etc) of the requirements in each target market. Review proposed labelling/instructions for use for compliance with applicable local and international regulations. Recommends changes for labelling and internal documentation, reports for regulatory compliance. Become the Subject Matter Expert (SME) for the Biological safety process. Coordinates multiple projects at one time and provides regular reports to regulatory management, clinical affairs and others as required. Works closely with Regulatory and Clinical Affairs to address biological aspects for submissions to EU/US regulators, including responding to requests from Regulators. Maintains an excellent understanding of the global medical device regulations especially with respect to Biocompatibility for example ISO 10993, and by identifying and critically assessing emerging standards, theories and methodologies and applying gained expertise within the Biological safety processes. Conduct comprehensive evaluations of biological risks associated with medical devices, ensuring compliance with ISO 10993 and regulatory requirements. Key Requirements: Level 8 Degree or Masters in Science or Engineering or similar Minimum of 3 years experience in a similar role in the medical devices industry. Regulatory experience in Medical Devices, Pharmaceuticals or similar regulated industry is required. Understanding of applicable guidelines and regulations, for example experience with ISO 10993 Experience with FDA regulatory requirements, European Medical Devices Regulation (EU MDR), Regulation (EU) 2017/745 and international regulatory agency requirements. Ability to effectively manage multiple projects and priorities. Has an excellent attention to detail and are results oriented. For further information please contact Loretta Flynn INDCRG Skills: regulatory affairs ISO 10993 EU MDR Biocompatability biological plans
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Regulatory Affairs Coordinator
5 days ago
County Dublin, Ireland Cpl Recruitment Full timeJob DescriptionThis is a hybrid role, requiring 2 days in the Dublin office and remote work. You will report to the Regulatory Affairs Manager and work closely with the Sales team.Key Responsibilities:Coordinate regulatory activities related to products on the Irish market.Manage product complaints, including documentation and communication with...
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Regulatory Affairs Expert
2 days ago
County Dublin, Ireland Cpl Resources - Teg Full timeAbout UsCpl Resources - Teg is a leading provider of quality control solutions. We are seeking a highly skilled Regulatory Affairs Expert to join our team.The successful candidate will be responsible for:Managing external analytical method transfer and new product introduction projects.Liaising with customers to support overall method transfer...
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Executive Assistant In Corporate Affairs
1 day ago
County Dublin, Ireland Hays Specialist Recruitment Ireland Ltd Full timeYour new company As Executive Assistant, you will join a reputable cultural institute known as Ireland's leading museum institution, with a strong emphasis on national and some international archaeology, Irish history, Irish art, culture, and natural history.Your new position is to assist in the management, development and implementation of the corporate...
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Corporate Affairs Administrator
1 day ago
County Dublin, Ireland Hays Specialist Recruitment Ireland Ltd Full timeJob Summary: We are seeking a highly skilled and experienced Executive Support Professional to join our team in Dublin. As an Executive Assistant, you will play a key role in the management, development, and implementation of the corporate affairs function within a reputable cultural institute. Key Responsibilities:Assist with the preparation and review of...
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Director of Regulatory Affairs
4 days ago
County Dublin, Ireland Blackhawk Network (Gvs) Full timeAbout the Role:The Head of Financial Crime Prevention will be responsible for ensuring that GVS Prepaid is compliant with the various regulatory rules.This role will involve maintaining an internal working document, procedures or knowledge base to ensure that regulatory information is shared and there is no single point of failure in relation to the...
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Regulatory Affairs Manager
4 days ago
County Dublin, Ireland Wallace Myers International Full timeWallace Myers International Recruitment Agency is seeking a skilled Financial Regulation Manager to join our team. The successful candidate will be responsible for the management of processes and procedures relating to the Regulation Committee.The committee, which meets to consider individual cases and policy issues, requires effective communication from the...
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Telecommunications Regulatory Expert
2 days ago
County Dublin, Ireland Three Ireland Full timeWe're seeking a Telecommunications Regulatory Expert to join our Executive Leadership Team as General Counsel.As a member of ELT, you will provide expert legal and regulatory advice to ensure compliance with industry regulations and mitigate key legal risks.You will oversee critical legal activities across all functions, including commercial negotiations and...
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Executive Director Medical Affairs Oncology
2 days ago
County Dublin, Ireland Regeneron Ireland Dac Full timeOur Medical Affairs physicians and scientists are experts on our medicines and form an extremely valuable part of our global development organization.We serve as an important liaison between Regeneron and the scientific and healthcare community.Medical Affairs is organized in an optimally aligned matrix structure for delivery of therapeutic and functional...
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Regulatory Compliance Specialist
1 day ago
County Dublin, Ireland Zurich Insurance Company Limited (Ireland Branch) Full timeJob SummaryZurich Insurance Company Limited (Ireland Branch) is seeking a highly motivated individual to join its Technical Services Team as a Regulatory Compliance Specialist. In this role, you will provide critical support to ensure the company's life and pensions products comply with regulatory and tax obligations.About the RoleYour responsibilities will...
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Regulatory Reporting Specialist
5 days ago
County Dublin, Ireland Abrivia Full timeAbout the RoleWe are seeking a Regulatory Reporting Specialist to join our team at Abrivia. As a key member of our dynamic team, you will play a critical role in supporting the preparation of Quarterly and Annual Reports for Pension Schemes.Key Responsibilities:Support report preparation: Collaborate with internal teams to develop and submit quarterly and...
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Regulatory Compliance Specialist
3 days ago
County Dublin, Ireland Abrivia Full timeJob DescriptionAbrivia is recruiting for a Regulatory Compliance Specialist to join our client's team as a Senior Compliance Officer - Data Protection. This is an excellent opportunity to work with a leading organisation in the Non-Life Insurance sector and contribute to their commitment to regulatory compliance.In this role, you will provide expert guidance...
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Regulatory Affairs Quality Manager
4 days ago
County Roscommon, Ireland FRS Recruitment Full timeQuality Engineer Job DescriptionWe are seeking an experienced Quality Engineer to join our team. As a Quality Engineer, you will play a crucial role in ensuring our production processes meet the highest quality standards.Responsibilities:Key responsibilities include:Providing ongoing quality support to maximise production performance and product...
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Regulatory Energy Specialist
7 days ago
County Dublin, Ireland Cpl Resources - Teg Full timeCpl Resources - Teg is currently seeking a highly skilled Regulatory Energy Specialist to join our team in the Decarbonisation Division. The successful candidate will have the opportunity to lead and deliver on projects within the energy-related area, researching and preparing information and decision papers for the Commission.You will manage public...
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County Dublin, Ireland Regeneron Ireland DAC Full timeOur Medical Affairs physicians and scientists are experts on our medicines and form an extremely valuable part of our global development organization. We serve as an important liaison between Regeneron and the scientific and healthcare community. Medical Affairs is organized in an optimally aligned matrix structure for delivery of therapeutic and functional...
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Regulatory Compliance Specialist
3 days ago
County Westmeath, Ireland Matrix Recruitment Group Full timeA Regulatory Compliance Specialist is required by our client's pharmaceutical start-up in Ireland to lead their quality assurance initiatives.This is a unique opportunity to join a fast-growing site at a pivotal stage, offering excellent career progression for the right candidate.You will play a key role in establishing the quality function alongside the...
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Regulatory Oversight Specialist
3 days ago
County Dublin, Ireland Sigmar Recruitment Full timeJob OverviewSigmar Recruitment is currently working with a leading client who seeks a Regulatory Oversight Specialist to join its team. This role involves leading reviews into financial or governance issues and conducting statutory investigations.Responsibilities:Lead reviews into financial or governance issues reported or identified through Notifiable...
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Product Quality Specialist
5 days ago
County Dublin, Ireland Cpl Recruitment Full timeWe are collaborating with a leading healthcare supplier, Braun. As a Product Quality & Complaints Coordinator, you will play a vital role in ensuring compliance with regulatory procedures and guidelines.Responsibilities:Support the Regulatory Affairs Manager in managing regulatory activities related to products on the Irish market.Manage product complaints...
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Regulatory Compliance Specialist
3 days ago
County Dublin, Ireland Fruition Group Full timeRole OverviewFruition Group is seeking a highly skilled Regulatory Business Analyst to join their team on a daily rate contract basis.The ideal candidate will have strong expertise in regulatory frameworks and insurance, with a particular focus on IFRS 17 implementation and compliance.This is a critical role supporting the insurance business in ensuring they...
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Regulatory Compliance Specialist
3 days ago
County Dublin, Ireland Cpl Recruitment Full timeAbout Cpl RecruitmentCpl in partnership with our client Pfizer are seeking a Quality Control Reference Material Specialist to join their team for an 11 month fixed term contract with hybrid working model.The role will be in the Quality Control Department in Pfizer Grange Castle as part of an expanding and diverse team of welcoming and supportive...
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Regulatory Reporting Specialist
3 days ago
County Dublin, Ireland Abrivia Full timeJob DescriptionThe Regulatory Reporting Analyst will be responsible for supporting the preparation of Quarterly and Annual Reports for Pension Schemes. This includes contributing to the development and submission of quarterly and annual regulatory reports to the Central Bank of Ireland.This role requires collaboration with internal teams, including pension...