Only 24h Left: Senior Regulatory Scientist
3 days ago
Overview Device Compliance/NPI: 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 functional areas. Responsibilities Assists in the running of the Cook Ireland regulatory affairs programmes in accordance with internal procedures and regulatory requirements. Responsibility for assisting in implementing regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA 21CFR Part 820 as required and other jurisdictions as required. Maintains an excellent understanding of the global medical device regulations. Maintains a thorough understanding of the products assigned to the team. Works to improve the function of the Regulatory Affairs Department. Understands the progress of the RA team on assigned tasks, and removes roadblocks. Provides support to the RA team members to complete assigned tasks. Mentors and trains new RA team members. Highlights any updates to regulatory requirements to regulatory management. Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations as needed or collaborates with their assigned regulatory specialists on same. Reviews submissions generated for their assigned regulatory area to ensure compliance to the regulations in that particular jurisdiction. Develops global regulatory strategies for Cook medical devices in collaboration with other regulatory affairs or clinical personal (as applicable), especially on high risk devices. Advise other Cook functional units (engineering, marketing, operations, quality etc) of the requirements in each target market and updates same on approval status in target markets. Ensures the clinical requirements of the product are adequately addressed. Ensure the outputs from the individual functional units (engineering, marketing etc.) meet the applicable regulatory requirements. Communicates status of projects / submissions directly to RA Management and other stakeholders as required. Communicates directly with regional regulatory agencies / notified bodies to ensure product clearances are achieved in a timely manner. Serves as a liaison on regulatory issues between the Cook Manufacturer and the Cook International local office and/or Cook distribution partner. Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required. Maintains a system for registration information (license numbers, expiration dates etc) and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability. Provides support to currently marketed products as necessary including input on change requests, etc. Maintains and organises appropriate regulatory records to demonstrate compliance with applicable regulations. Provides regulatory support to Cook functional units such as the SSC, tenders, customer quality and distribution. Is a delegate for the Senior Manager Post Market Surveillance, Regulatory Affairs / Manager, Regulatory Affairs, Principal Regulatory Scientist. Is a delegate for the Regulatory Affairs Specialist. Is a delegate for the Team Lead, Regulatory Affairs. Qualifications Third level Qualification preferably in Science/Quality Engineering or Clinical (such as Pharmacy or Nursing) 5 years' experience in a regulated industry in a similar role is desirable. Ideally have knowledge of requirements in MDSAP countries including regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA 21CFR Part 820 as required. Knowledge of requirements in other jurisdictions where required. Knowledge of medical device quality standards/practises or similar regulated industry. Good communication and inter-personal skills. Proven problem-solving skills. Good computer skills including knowledge of Microsoft Proven organisational skills. High self-motivation. Willingness and availability to travel on company business. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
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Scientist - Bioprocessing
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Limerick, Ireland FRS Recruitment Full timeBioprocessing Scientist Fancy working in a new state of the art biotech company in the Mid -West region with close proximity to Shannon Airport/M18/Galway/Limerick? I am both privileged and excited to be assisting this new biotech company in the Mid -West to recruit for a Bioprocessing Scientist . This company has invested millions into their high-tech...
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Senior Principal Scientist
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Limerick, Ireland Eli Lilly and Company Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
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Senior Bioprocess Scientist
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Limerick, Ireland Eli Lilly and Company Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
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Materials Management Scientist
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Limerick, Ireland MATRIX Recruitment Group Full timeWhat You Need to Know: Matrix Recruitmentare seeking an Associate Relationship Manager for our global financial services client, based in Limerick. This is a 12-month contract role with potential opportunity for extension or development. This company offers a hybrid working model with 2 days from home. What You Will Be Doing: Act as the main point of contact...
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▷ [Only 24h Left] Principal Data Engineer
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Limerick, Ireland 1020 ADBV Ireland Full timeAnalog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably...
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Environmental Scientist
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Limerick, Ireland FRS Recruitment Full timeA new role for a Environmental Scientist has just become available for a pharmaceutical company in Limerick. 1 yrs’ min GMP industry experience required If you have some or all of the skills listed below together with a scientific degree and at least 12 months experience working in a GMP environment then I'd love to hear from you. Duties - Perform...
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Limerick, Ireland Life Science Recruitment Full time(Senior) Manufacturing Engineers - Global Medical Devices My client is a leading global medical devices innovator and manufacturer, currently seeking Manufacturing Engineers at all levels for their state of the art Limerick facility. You will join a fast-paced, innovative, and progressive team where career progression is a pivotal part of the company...
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Scientist/Sr Scientist/Principal Scientist
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Limerick, Ireland Eli Lilly and Company Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
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[15h Left] Medical Scientist, Staff Grade
4 days ago
Limerick, Ireland OASIS Group Full timeMedical Scientist, Staff Grade (Histology) - Limerick, Ireland - Permanent, Full time Who We Are Six Health Regions have been established within the HSE, on the basis of the geographical boundaries agreed by the Government in July 2019. Each Health Region will be tasked with population specific planning, resourcing, and delivery of health and social care...
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Limerick, Ireland QA Resources Full timeSenior Regulatory Officer Industry: Medical Device Department: Regulatory Affairs Role Summary – Major Activities: 1. Provide coaching and support to all employees on the regulatory team. 2. Ensure employees understand their duties/delegated tasks. 3. Prepare and maintain IVDR compliant technical files utilising information from cross functional...
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Only 24h Left! DELTAV SYSTEM ADMINISTRATOR
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Limerick, Ireland Réalta Technologies Full timeRéalta Technologies is currently searching for DeltaV System Administrator to support a client of ours in the Life Sciences industry based in Limerick. The ideal candidate will ideally have a strong industrial automation or OT/Infrastructure background and excellent problem solving skills. Responsibilities - Perform regular system checks, diagnostics and...
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Limerick, Ireland Regeneron Ireland DAC Full timeWithin this role you will be responsible for providing expertise and leadership in the quality function. You will be responsible to ensure that licensed product is certified and released to market in compliance with commercial manufacturing license and clinical (IMP) products. As an Associate Director Qualified Person a typical day might include, but is not...
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Limerick, Ireland Regeneron Ireland DAC Full timeWithin this role you will be responsible for providing technical leadership and mentorship for qualification activities and data integrity initiatives in regard to small manufacturing and laboratory equipment (e.g. HPLC/UPLC, TOC analyser, FTIR, microscopes) in the frame of Industrial Operations and Product Supply of biological products in accordance with...
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Only 24h Left: Software Test Engineer
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Limerick, Ireland BD Medical Full timeJob Description Summary As a Software Test Engineer, you will be part of a team of R&D Engineers that work on sustaining projects in IDS product engineering. You will be encouraged to support the verification and validation efforts of medical devices/systems regarding sustaining engineering. You will work as part of an R&D team in delivering sophisticated...
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Limerick, Ireland RedChair Recruitment Full timeWe are presently recruiting for a Toolmaker / Setter for our clients in West County Limerick. You will be involved in new designs, constructs, repairs, and maintains precision tools, dies, moulds and special guiding and holding devices that are used in manufacturing processes within the plant that produces roughly 30 Billion products per year. This is a full...
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(Only 24h Left) Senior Quantity Surveyor
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Limerick, Ireland ICDS Group Full timeSenior Quantity Surveyor (developer) - Limerick - €120K New opportunity for a Senior Quantity Surveyor to join a Property development company in Limerick, Ireland. They have over 40 years of experience delivering quality developments in Ireland, UK and Europe. Duties include: Prepare feasibility studies: The successful candidate will be responsible for...
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Limerick, Ireland 1020 ADBV Ireland Full timeSenior Robotics AI/ML Engineer Location: Ireland, Limerick Time Type: Full time Posted On: Posted 27 Days Ago Job Requisition ID: R244284 Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies...
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Limerick, Ireland Northern Trust Full timeAbout Northern Trust: Northern Trust, a Fortune 500 company, is a globally recognized, award-winning financial institution that has been in continuous operation since 1889. Northern Trust is proud to provide innovative financial services and guidance to the world's most successful individuals, families, and institutions by remaining true to our enduring...
