Current jobs related to Medical Regulatory Strategist - Limerick, Limerick - Cook Medical
-
Global Medical Device Strategist
4 days ago
Limerick, Limerick, Ireland Cook Medical Full timeWe are looking for a talented Global Medical Device Strategist to join our team at Cook Medical. As a key member of our regulatory affairs department, you will be responsible for developing and implementing global regulatory strategies for our medical devices.Key ResponsibilitiesDevelop global regulatory strategies for Cook Medical devices in collaboration...
-
Regulatory Affairs Specialist
4 days ago
Limerick, Limerick, Ireland Cook Medical Full timeOverviewCook Medical is a leading manufacturer of medical devices, and we are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will play a crucial role in ensuring that our products meet the highest standards of quality and safety.ResponsibilitiesAssist in the running of Cook...
-
Regulatory Scientist 2
17 hours ago
Limerick, Limerick, Ireland Cook Medical Full timeOverview Clinical & Post Market Surveillance: The 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...
-
Regulatory Affairs Specialist
6 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 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...
-
Regulatory Affairs Specialist
10 hours ago
Limerick, Limerick, Ireland Cook Medical Full timeCook Medical is seeking a highly skilled Regulatory Scientist 2 to join our team. In this role, you will be responsible for developing and implementing regulatory strategies to ensure compliance with global medical device regulations.Key Responsibilities:Maintain an excellent understanding of global medical device regulations in relation to post-market...
-
Regulatory Scientist 2
3 hours 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 (CEPs,...
-
Medical Device Compliance Manager
6 days ago
Limerick, Limerick, Ireland Cook Medical Full timeRegulatory ExpertiseThe Regulatory Scientist 2 is responsible for ensuring that Cook medical devices comply with global medical device regulations for specific jurisdictions. Key areas of expertise include: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 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 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...
-
Compliance Officer for Medical Devices
3 days ago
Limerick, Limerick, Ireland Cook Medical Full timeCook Medical is a leading manufacturer of medical devices, and we are seeking a highly skilled Compliance Officer for Medical Devices to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring that our products meet the highest standards of quality and safety.Key ResponsibilitiesAssist in the implementation...
-
Global Regulatory Strategy Lead
6 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...
-
Global Medical Device Compliance Manager
6 hours ago
Limerick, Limerick, Ireland Cook Medical Full timeCook Medical's Regulatory Scientist 2 plays a critical role in ensuring the company's medical devices comply with global regulations. The ideal candidate will have experience in regulated industries and a strong understanding of post-market surveillance and clinical evaluation regulations.Responsibilities:Develop and implement regulatory strategies to ensure...
-
Regulatory Affairs Expert
7 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...
-
3 Days Left: Regulatory Scientist 2
1 week 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
7 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...
-
Senior Medical Device Specialist
7 days ago
Limerick, Limerick, Ireland Cook Medical Full timeCompany Overview:Cook Medical is a leading manufacturer of medical devices, committed to improving patient outcomes through innovative products and services.Our company values innovation, quality, and customer satisfaction, and we strive to maintain the highest standards in our operations and regulatory compliance.We are seeking a highly skilled and...
-
Technical Project Lead Medical Devices
3 days ago
Limerick, Limerick, Ireland Cook Medical Incorporated Full timeJob Summary:Cook Medical Incorporated is seeking an experienced Technical Project Lead Medical Devices to join our Research and Development team. As a key member of our engineering team, you will be responsible for leading product development projects from concept to launch. This role involves working closely with cross-functional teams to ensure the...
-
Medical Device Regulatory Manager
4 days ago
Limerick, Limerick, Ireland TN Ireland Full timeJob SummaryWe are seeking a Senior Regulatory Officer to join our team at TN Ireland.About the PositionSupport implementation of company regulatory strategies and providing guidance and expertise.Compiling and communicating regulatory requirements and gap analysis assessments to multi-functional groups in a concise and precise manner.Key RequirementsA...
-
Medical Device Regulatory Professional
3 days ago
Limerick, Limerick, Ireland TN Ireland Full timeJob OverviewThis Regulatory Affairs Specialist 2 role is responsible for ensuring EU MDR compliance at the EU Authorised Representative office. The successful candidate will act as a liaison between Cook Medical's non-EU manufacturers and the EU regulatory authorities.Key AccountabilitiesCultivate and maintain an exceptional understanding of EU medical...
Medical Regulatory Strategist
1 week ago
Cook Medical is a leader in the development and manufacturing of medical devices. Our products are designed to improve patient outcomes and enhance the quality of life. We are committed to providing exceptional customer service and support to our customers.
The ideal candidate will have a third-level qualification in a relevant field, such as science, engineering, or clinical disciplines. They will also have at least 2 years' experience in a regulated industry in a similar role. Knowledge of regulations pertaining to post-market surveillance and clinical evaluation would be advantageous.
Required Skills and Qualifications:
- Strong knowledge of global medical device regulations
- Excellent communication and interpersonal skills
- Able to work independently and as part of a team
- Proven problem-solving skills
- Good technical writing skills
- Familiarity with search databases for published literature