![ICON Clinical Research](https://media.trabajo.org/img/noimg.jpg)
Regulatory Affairs Specialist- Medical Devices
1 month ago
At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.
Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.
That's our vision. We're driven by it. And we need talented people who share it.
If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.
The role:
• Responsible for providing advice and support to the project team for regulatory operations aspects of the projects.
• Manage and ensure maintenance of a positive and productive liaison with internal and external contacts (i.e. regulatory agencies, clients, co-workers, staff, etc.)
• Maintain a strong customer service management approach with clients.
• Lead project teams and advise departments on regulatory standards issues and strategies
• Develop, write, and implement standards and procedures related to regulatory operations.
• Identify client issues and develop alternative strategies for presentation to client consulting with other resources within organization as required
• Participate actively in other business related projects (business opportunities, client specific issues, etc.) and planning.
• Client consultation and preparation of quotes and is responsible for achieving utilization goals of the EU unit.
• Completing other appropriate duties as assigned by line manager that require similar skills
You will need:
• Experience in eCTD, NeeS, Paper Submissions.
• Experience in EU, US and Canada HA submissions.
• Experience in Lorenz Docubridge and ISI Tool Box
• Experience in sequence building and document level publishing
• Good knowledge on the CTD sections.
Benefits of Working in ICON:
Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.
We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.
ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
-
Regulatory Affairs Specialist- Medical Devices
2 weeks ago
Dublin, Dublin City, Ireland ICON Full timeAt ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration,...
-
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...
-
Senior Regulatory Scientist
2 weeks ago
Dublin, Dublin City, Ireland Cook Medical Incorporated Full timeOverview The primary role of the Senior Regulatory Scientist is to assist in the running of the regulatory affairs by providing input into: regulatory strategies, performing activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets and providing regulatory affairs input for the...
-
Regulatory Affairs Specialist
2 weeks ago
Dublin, Dublin City, Ireland Collins McNicholas Recruitment Full timeWe have a new opening for aRegulatory Affairs Specialistto join a well-established but rapidly growing international healthcare business based inTullamore, Co Offaly. It is a great chance to be part of an organization that makes a real impact on millions of lives. The company have asignificant presence in Ireland the UK and mainland Europe. This is...
-
Senior Manager, Regulatory Affairs
2 weeks ago
Dublin, Dublin City, Ireland Regeneron Pharmaceuticals, Inc Full timeRegeneron is advancing its pipeline portfolio using a data-driven human translational approach. The In Vitro Diagnostic (IVD) Regulatory Affairs (RA)Team along with the Regulatory Affairs Global Regulatory Strategy Group (GRS) collaborate with the Precision Medicine and Clinical Sciences Teams to help develop and execute biomarker strategies across its...
-
Regulatory Affairs
2 weeks ago
Dublin, Dublin City, Ireland Life Science Recruitment Full timeRegulatory Affairs - Complaints Co-OrdinatorAMC0010Regulatory Affairs - Complaint Co-ordinator6 month contractHybrid - Dublin - D12Product Complaints Coordinator RoleMain tasks:Management of product complaints for products on the Irish market, from initial receipt through to closure, in conjunction with the company's Global Complaints Departments and in...
-
Regulatory Affairs Specialist
2 weeks ago
Dublin, Dublin City, Ireland Glanbia Full timeThe OpportunityThe Regulatory Affairs Specialist is responsible for supporting product commercialization, for GPN owned and contract brands, for all activities involving regulatory compliance from concept to launch. This role will play a critical role in delivery of the growth objectives of the EMEA region.Ensuring Product Compliance to local...
-
Regulatory Affairs Specialist
2 weeks ago
Dublin, Dublin City, Ireland Glanbia Nutritionals, Inc. Full timeSelect how often (in days) to receive an alert: John this dynamic team focused on delivering better nutrition for every step of life's journey The Opportunity The Regulatory Affairs Specialist is responsible for supporting product commercialization, for GPN owned and contract brands, for all activities involving regulatory compliance from concept to...
-
Medical Device Specialist
2 weeks ago
Dublin, Dublin City, Ireland GlaxoSmithKline Full timeSite Name: Ireland - DublinPosted Date: Jun 6 2024As a Medical Device Specialist, you will be preparing dossiers for the batch verification of medical devices. This will involve reviewing batch deviations, change controls and test results.We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a...
-
Dublin, Dublin City, Ireland Cpl Healthcare Full timeMy client, one of the world's leading health care suppliers are looking for a motivated, innovative, and enthusiastic Regulatory Affairs Product Complaints Coordinator to join their team in Dublin. This is a 6-month contract position. Very competitive benefits package included and offering a Hybrid work (2 days in the office per week)The Role ·Management of...
-
Pharmacy Regulatory Affairs Manager
2 weeks ago
Dublin, Dublin City, Ireland The Boots Company PLC Full timeThis position plays a significant role in ensuring the safety and authorization of healthcare products for the Irish market, while also maintaining compliance with legal and regulatory standards:Verify the safety and authorization of healthcare products sold in IrelandEnsure that healthcare promotions and advertising adhere to legal guidelinesEstablish...
-
Medical Affairs Scientist
2 weeks ago
Dublin, Dublin City, Ireland Cpl Healthcare Full timeCpl in partnership with our client Pfizer are seeking a Medical Affairs Scientist to join the team for an 12 month fixed term contract in their Dublin, Ringsend site. This role has a hybrid working model attached.Role Description•The Medical Affairs Scientist will be responsible to provide in country medical affairs support that is aligned and integrated...
-
Regulatory Affairs Manager
2 weeks ago
Dublin, Dublin City, Ireland Cpl Healthcare Full timeRegulatory Affairs Manager This position will be responsible for ensuring efficient and productive regulatory submissions for UK/I, as well as assisting and collaborating in strategic drug development program implementation for Europe. This individual will provide support for the preparation of UK/I and EU regulatory submissions including but not limited to...
-
Head of Medical Affairs, CMR, Ireland
2 weeks ago
Dublin, Dublin City, Ireland Novo Nordisk Full timeExciting Opportunity - Head of Medical Affairs IrelandAre you ready to lead a team of dedicated medical advisors and have a knack for coaching and developing people? Do you specialize in therapeutic fields like Diabetes, Obesity, Cardiovascular Diseases, or Rare Diseases? Are you passionate about driving positive change for patients in these areas? Have you...
-
Medical Affairs Scientist New
2 weeks ago
Dublin, Dublin City, Ireland CPL Full timeCpl in partnership with our client Pfizer are seeking a Medical Affairs Scientist to join the team for an 12 month fixed term contract in their Dublin, Ringsend site. This role has a hybrid working model attached. Role Description The Medical Affairs Scientist will be responsible to provide in country medical affairs support that is aligned and integrated to...
-
Director, Global Regulatory Affairs, Pediatrics
2 weeks ago
Dublin, Dublin City, Ireland Gilead Sciences, Inc. Full timeDirector, Global Regulatory Affairs, Pediatrics page is loaded Director, Global Regulatory Affairs, Pediatrics Apply locations Ireland - Dublin time type Full time posted on Posted 3 Days Ago job requisition id R For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. At Gilead, we're creating a...
-
Senior Scientific Affairs Specialist
2 weeks ago
Dublin, Dublin City, Ireland ICON Full timeAt ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration,...
-
Engineer 2, Post Market
2 months ago
Dublin, Dublin City, Ireland Cook Medical Incorporated Full timeOverviewJoin our team in a key role where you will lead engineering projects focused on maintaining device quality and compliance while reducing costs and increasing yields. Reporting to the Team Lead, Post Market Engineering.ResponsibilitiesLead or participate in projects in areas such as CAPA or Design.Collaborate with Engineering Teams for effective...
-
Engineer 2, Post Market
4 weeks ago
Dublin, Dublin City, Ireland Cook Medical Incorporated Full timeOverviewJoin our team in a key role where you will lead engineering projects focused on maintaining device quality and compliance while reducing costs and increasing yields. Reporting to the Team Lead, Post Market Engineering.ResponsibilitiesLead or participate in projects in areas such as CAPA or Design.Collaborate with Engineering Teams for effective...
-
Graduate Level Regulatory Affairs Officer
2 weeks ago
Dublin, Dublin City, Ireland Azon Full timeRole:Exciting Opportunity: Join a leading chemical manufacturer in North DublinType:Duration: Permanent role in North Dublin collaborating closely with Azon Recruitment Group. This company is known for its strong employee retention, internal advancement opportunities, and competitive compensation packagesAbout the position: This role offers the chance to be...