Medical Device Regulatory Affairs Specialist
3 days ago
Company Overview
">Teleflex is a global provider of medical technologies driven by our purpose to improve the health and quality of people's lives. We offer a diverse portfolio with solutions in various therapy areas, including anesthesia, emergency medicine, interventional cardiology, radiology, surgical, vascular access, and urology.
">We believe that great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare. Our trusted brands, such as Arrow, Barrigel, Deknatel, QuikClot, LMA, Pilling, Rüsch, UroLift, and Weck, are united by a common sense of purpose.
">Job Description
">The Sr. Regulatory Affairs Associate will support regulatory activities leading to and maintaining regulatory compliance and approval for Teleflex Medical products in the EMEA region. Key responsibilities include coordinating and managing regulatory and product registration activities, providing RA input for projects, preparing internal reports and change control documents, and reviewing documents for potential impact on global regulatory submissions.
">This role also involves preparing product registration files for submission to global regulatory bodies/agencies, participating in project work such as new product introductions and changes to existing products and processes, and supporting maintenance of product registration database.
">Required Skills and Qualifications
">To be successful in this role, you should have a degree in a relevant Science or Engineering discipline and 2-3 years of medical device industry experience within quality or regulatory. Technical writing expertise and basic knowledge of US and/or international medical device regulations, standards, and guidance documents are also essential.
">Project Management skills and experience are required, along with self-driven and ability to work independently and/or as a team player. Good organisational skills with cultural awareness and sensitivity, good judgment, and problem-solving ability are also necessary.
">Benefits
">As a Sr. Regulatory Affairs Associate at Teleflex, you will have the opportunity to work on exciting projects and collaborate with a talented team of professionals. You will also receive competitive compensation and benefits package.
">Others
">Teleflex is an equal opportunity employer and values diversity and inclusivity in the workplace. If you require accommodation and support to apply for a position, please contact us.
">We follow a comprehensive hiring process and do not accept unsolicited resumes from agency recruiters or 3rd party firms.
-
Dublin, Dublin City, Ireland Vectura Group Full timeJob SummaryWe are seeking an experienced Regulatory Affairs Specialist to contribute to our regulatory activities, ensuring the successful and timely approval of relevant medical device submissions.This role will ensure global regulatory compliance while supporting Vectura's corporate goals. The successful candidate will provide strategic regulatory guidance...
-
Dublin, Dublin City, Ireland Vectura Group Full timeAbout Us:Vectura Group is a global leader in the development and delivery of inhaled medicines and medical devices. We are dedicated to innovation, quality, and compliance in delivering effective treatments for patients worldwide.Job Summary:We are seeking an experienced Manager - Regulatory Affairs and Medical Devices to contribute to our regulatory affairs...
-
Dublin, Dublin City, Ireland Vectura Group plc Full timeSenior Manager Regulatory Affairs for Medical Devices and Person ResponsibleVectura Ireland Limited is seeking a Senior Manager in Regulatory Affairs for Medical Devices who will also assume the critical role of Person Responsible for Regulatory Compliance (PRRC). This position plays a key role in ensuring compliance with European medical device regulations...
-
Senior Regulatory Affairs Specialist
2 weeks ago
Dublin, Dublin City, Ireland Life Science Recruitment Full timeSenior Regulatory Affairs SpecialistOur client a high potential medical device start up current seeks a Senior Regulatroy Affairs Specialist to join their team. Reporting to the Director of Quality and Regulatory Affairs the Senior Regulatory Affairs will take an active role in developing the Regulatory strategy in Europe and the US and interacting with the...
-
Medical Device Specialist
3 days ago
Dublin, Dublin City, Ireland TN Ireland Full timeJob Summary:We are seeking an experienced Medical Device Specialist to lead our regulatory affairs function. The successful candidate will be responsible for ensuring that our products comply with all relevant regulations.The ideal candidate will have a minimum of 3-5 years' experience in a medical device/healthcare industry in a regulatory position and...
-
Medical Device Specialist
5 hours ago
Dublin, Dublin City, Ireland Sigmar Recruitment Full timeThis is an excellent opportunity for a Medical Device Specialist to join our team and contribute to the success of our clients. As a Regulatory Compliance Officer, you will be responsible for ensuring that medical products meet regulatory requirements, providing advice on new legislation, and coordinating product compliance data collection and assessment.Key...
-
Regulatory Affairs Specialist
6 days ago
Dublin, Dublin City, Ireland Life Science Recruitment Ltd Full timeCompany Overview:Life Science Recruitment Ltd is a leading recruitment agency specializing in the life sciences industry. Our team of experts has years of experience matching talented professionals with top companies in the field.Job Description:We are currently recruiting for a Clinical Affairs Specialist to join our client, a medical device company. As a...
-
EU Regulatory Affairs Specialist
3 days ago
Dublin, Dublin City, Ireland Sigmar Recruitment Full timeJob DescriptionThe Regulatory Compliance Specialist will be responsible for ensuring that all medical products meet regulatory requirements. This includes maintaining product registrations, acting as EUAR and UKRP, and managing post-market actions.Key ResponsibilitiesMaintain product registrations in all territories.Act as EUAR and UKRP for partners.Manage...
-
Regulatory Affairs Specialist
3 days ago
Dublin, Dublin City, Ireland TN Ireland Full timeJob DescriptionCompany OverviewTN Ireland is a leading provider of innovative solutions in the medical device industry.Job SummaryWe are seeking a highly skilled and experienced Regulatory Affairs Specialist to join our team.Key ResponsibilitiesAct as Regulatory Affairs lead for new product development projects, providing solution-based advice to development...
-
Regulatory Affairs Manager
2 days ago
Dublin, Dublin City, Ireland TN Ireland Full timeThis 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...
-
Device Regulatory Strategy Lead
2 days ago
Dublin, Dublin City, Ireland TN Ireland Full timeTN Ireland is seeking an entrepreneurial business-oriented mindset and a strong fit with our team for this hybrid role based in Dublin HQ. As a Senior Director Regulatory Affairs Device, you will bring passion, energy and enthusiasm to define the device regulatory strategy and oversee all device submissions across global markets.Job Description:This role...
-
Director Regulatory Affairs
3 days ago
Dublin, Dublin City, Ireland TN Ireland Full timeSocial network you want to login/join with:Director Regulatory Affairs - Device, DublinClient: The RFT GroupLocation: Dublin, IrelandJob Category: OtherEU work permit required: YesJob Reference: 8f16f2ec00f7Job Views: 110Posted: 21.01.2025Expiry Date: 07.03.2025Job Description:Senior Director Device Regulatory AffairsThis is a rare opportunity to join a...
-
Regulatory Affairs Specialist
3 days ago
Dublin, Dublin City, Ireland TN Ireland Full timeSocial network you want to login/join with:Regulatory Affairs Specialist, WestmeathClient: Critical HealthcareLocation: Westmeath, IrelandJob Category: OtherEU work permit required: YesJob Reference: 6db5ec06c42aJob Views: 120Posted: 21.01.2025Expiry Date: 07.03.2025Job Description:We have a new opening for a Regulatory Affairs Specialist to join a...
-
Compliance Manager
3 days ago
Dublin, Dublin City, Ireland Sigmar Recruitment Full timeAbout the RoleWe are seeking an experienced Regulatory Compliance Specialist to join our team. The successful candidate will be responsible for overseeing regulatory compliance for medical products procured, stored, transported, and sold by all companies operating in Ireland, UK, and Switzerland.Main AccountabilitiesOversee regulatory compliance for medical...
-
Director Regulatory Affairs
4 weeks ago
Dublin, Dublin City, Ireland The RFT Group Full timeJob Description Senior Director Device Regulatory Affairs This is a rare opportunity to join a young, exciting clinical-stage biotechnology company. Our client is focused on the discovery and development of novel therapies, with the potential to fundamentally change the course of progressive, debilitating diseases. 2023 has been a year of highly...
-
Regulatory Affairs Manager
2 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...
-
Medical Device Regulatory Lead
3 days ago
Dublin, Dublin City, Ireland TN Ireland Full timeJob DescriptionKey ResponsibilitiesDevelop and implement regulatory strategies for new and modified products/product families.Prepare and execute regulatory filings such as technical files, Canadian submissions, and letters to file.Conduct international registrations in accordance with and in support of regulatory strategies.Provide input on and approve...
-
Medical Device Compliance Manager
6 days ago
Dublin, Dublin City, Ireland Life Science Recruitment Ltd Full timeAbout the Role:The Clinical Affairs Specialist will be responsible for ensuring compliance with good clinical practice regulations and coordinating clinical trials. This role requires excellent communication and interpersonal skills, as well as experience in the medical device or pharmaceutical industry. The ideal candidate will have a strong understanding...
-
Director of Global Medical Device Regulation
2 days ago
Dublin, Dublin City, Ireland TN Ireland Full timeAs a Senior Director Regulatory Affairs Device, you will be responsible for leading 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.Job Description:You will...
-
Regulatory Affairs Specialist
2 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...