Regulatory Scientist 2
2 days ago
Overview 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. Reporting to: Principal Regulatory Scientist 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. Knowledge of relevant ISO, EU, FDA medical device standards regulations is 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. Other General Responsibilities Ensure that Cook's Code of Conduct is considered in all business matters carried out on Cook's behalf. Perform additional duties as assigned. Qualifications Third level Qualification in any of the following areas: Science, Engineering, or Clinical. 2 years' experience in a regulated industry in a similar role would be advantageous. Knowledge of regulations pertaining to Post-market Surveillance and Clinical Evaluation would be advantageous. Particularly in relation to the EU (MDD 93/42/EEC, EU MDR 2017/745). (Clinical & Post Market Surveillance Role) 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 QSP 21CFR Part 820 as required. Good communication and inter-personal skills with ability to communicate clearly and concisely in both spoken and written form. Participate in a team-based environment. Proven problem-solving skills. Good technical writing skills; advantageous to have medical writing experience. Knowledge / use of search databases for published literature (Embase, PubMed etc.) Good computer skills including knowledge of Microsoft Office. Proven organisational skills. High level of self-motivation. Willingness and availability to travel on company business as required. 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.
-
Regulatory Scientist 2
3 days ago
Limerick, Limerick, Ireland Cook Medical Full timeOverview The Regulatory Scientist 2 helps develop regulatory strategies, performs activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets.The Regulatory Scientist 2 serves as a communication liaison between the Cook manufacturer and the Cook local affiliates or regulatory...
-
Regulatory Scientist 2
2 weeks ago
Limerick, Limerick, Ireland Cook Medical Incorporated Full timeOverviewThe Regulatory Scientist 2 will be involved in the development and generation of post market surveillance (PMS) plans and reports for Cook Ireland medical devices. In addition, the Regulatory Affairs Specialist will perform activities associated with PMS, including Post Market Clinical Follow-Up (PMCF), and Clinical Evaluation Plans and Reports...
-
3 Days Left: Regulatory Scientist 2
6 days ago
Limerick, Limerick, Ireland Cook Medical Full timeOverview The Regulatory Scientist 2 helps develop regulatory strategies, performs activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets. The Regulatory Scientist 2 serves as a communication liaison between the Cook manufacturer and the Cook local affiliates or regulatory...
-
Only 24h Left: Regulatory Scientist 2
4 days ago
Limerick, Limerick, Ireland Cook Medical 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
3 weeks ago
Limerick, Limerick, Ireland Cook Medical Full timeOverview The Regulatory Affairs Specialist 2 ensures regulatory compliance to the EU MDR at the office of the EU Authorised representative (AR). The EU AR Office is responsible for verifying compliance to the EU MDR on behalf of Cook Medical's non-EU manufacturers. The Regulatory Affairs Specialist 2 serves as a communication liaison between the Cook...
-
Regulatory Affairs Specialist 2
5 days ago
Limerick, Ireland Cook Medical Full timeOverview The Regulatory Affairs Specialist 2 ensures regulatory compliance to the EU MDR at the office of the EU Authorised representative (AR). The EU AR Office is responsible for verifying compliance to the EU MDR on behalf of Cook Medical’s non-EU manufacturers. The Regulatory Affairs Specialist 2 serves as a communication liaison between the...
-
Regulatory Affairs Specialist 2
4 weeks ago
Limerick, Ireland TN Ireland Full timeSocial network you want to login/join with:Regulatory Affairs Specialist 2 (Hybrid), LimerickClient:Cook MedicalLocation:Limerick, IrelandJob Category:OtherEU work permit required:YesJob Reference:5c63328c9fe6Job Views:65Posted:22.01.2025Job Description:OverviewThe Regulatory Affairs Specialist 2 ensures regulatory compliance to the EU MDR at the office of...
-
Limerick, Ireland TN Ireland Full timeSocial network you want to login/join with:Principal Scientist- Global Regulatory Affairs-CMC, LimerickClient:LillyLocation:Limerick, IrelandJob Category:OtherEU work permit required:YesJob Reference:29051c1083f9Job Views:120Posted:21.01.2025Expiry Date:07.03.2025Job Description:We’re looking for people who are determined to make life better for people...
-
Limerick, Limerick, Ireland Lilly Full timeWe're looking for people who are determined to make life better for people around the world. Organization Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver...
-
Limerick, Ireland Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. Organization Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver...
-
Global Regulatory Strategy Lead
3 days ago
Limerick, Limerick, Ireland Cook Medical Full timeResponsibilities and DeliverablesThe Regulatory Scientist 2 is accountable for:Maintaining up-to-date knowledge of global medical device regulations for specific jurisdictions.Developing and implementing regulatory strategies for Cook medical devices.RequirementsTo be considered for this role, you will need:Excellent communication and inter-personal...
-
2/23/2025 A) Senior Principal Scientist
4 weeks ago
Limerick, 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...
-
Regulatory Affairs Specialist
3 days ago
Limerick, Limerick, Ireland Cook Medical Full timeJob OverviewThe Regulatory Scientist 2 plays a vital role in developing regulatory strategies, ensuring compliance with global medical device regulations for specific jurisdictions.Maintains an excellent understanding of regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA QSP 21CFR Part...
-
Regulatory Affairs Expert
4 days ago
Limerick, Limerick, Ireland Cook Medical Full timeJob Description:The Senior Regulatory Scientist role is a critical position in the regulatory affairs team, responsible for assisting in the running of regulatory programmes and providing input into regulatory strategies.Key responsibilities include implementing regulatory requirements, maintaining an excellent understanding of global medical device...
-
Senior Scientist
3 weeks ago
Limerick, Limerick, Ireland Cpl Healthcare Full timeSenior ScientistMaterials Management- Technical Services/Manufacturing SciencesOur biopharma client, based in Limerick, is a global healthcare leader dedicated to discovering and delivering life-changing medicines to improve the lives of people around the world. With a strong focus on innovation and collaboration, they aim to enhance the understanding and...
-
Regulatory Affairs Specialist 2
4 weeks ago
Limerick, Ireland Cook Medical Incorporated Full timeOverview The Regulatory Affairs Specialist 2 helps develop regulatory strategies, performs activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets. The Regulatory Affairs Specialist 2 serves as a communication liaison between the Cook manufacturer and the Cook local affiliates,...
-
Regulatory Affairs Specialist 2
4 weeks ago
Limerick, Ireland Cook Medical Full timeOverview The Regulatory Affairs Specialist 2 helps develop regulatory strategies, performs activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets. The Regulatory Affairs Specialist 2 serves as a communication liaison between the Cook manufacturer and the Cook local affiliates,...
-
Regulatory Affairs Specialist 2
4 weeks ago
Limerick, Ireland Cook Medical Incorporated Full timeOverviewThe Regulatory Affairs Specialist 2 helps develop regulatory strategies, performs activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets. The Regulatory Affairs Specialist 2 serves as a communication liaison between the Cook manufacturer and the Cook local affiliates,...
-
Global Regulatory Compliance Manager
3 days ago
Limerick, Limerick, Ireland Cook Medical Full timeRole Summary:This is an exciting opportunity for a highly skilled and experienced professional to join our regulatory affairs team as a Senior Regulatory Scientist.The successful candidate will be responsible for assisting in the running of regulatory programmes, providing input into regulatory strategies, and ensuring compliance with relevant ISO, EU, and...
-
Principal Scientist
3 weeks ago
Limerick, Limerick, Ireland CareerWise Recruitment Full timeJob Description A Principal Scientist: Global Regulatory Affairs (CMC) is required on a PERMANENT basis by CareerWise Recruitment for our Limerick based start-up Biopharmaceutical Client. The purpose of the role is to provide strategic, tactical and operational direction to expedite CMC development of Client portfolio and technical agenda by supporting...
