
Regulatory Communications Specialist
1 week ago
Reporting to: Regulatory Communications Team Lead Responsibilities Assess complaints from Cook global customer support and delivery centres for adequate information to determine if event meets Regulatory Reporting requirements.
Utilize appropriate complaint software systems for processing complaints to/from customer support and delivery centres and QE Investigation functions.
Generate appropriate regulatory reports based on assessment.
Liaise effectively with regulators on all issues with regard to regulatory reporting.
Ensuring that confirmed reportable events are escalated to the appropriate personnel in a timely manner.
Communicate with other Cook Companies globally as necessary for reporting.
Generate responses to inquiries on AE reports from various global regulatory authorities.
Generate various reports, including but not limited to, Regulatory requests, Marketing requests, Engineering requests.
Input into the assessment of field action through the Health Risk Assessment process.
Assist in coordination of Field Action administration activities between manufacturer and distribution centre.
Close out of complaints as necessary.
Input and adherence to the scheduling and management of Post Market Surveillance (PMS) plans and reports.
Maintains appropriate regulatory records to demonstrate compliance with applicable regulations.
Maintain an excellent understanding of global medical device regulations.
Responsibility for implementing applicable regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA QSP 21 CFR Part 820 as required.
Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required.
Serves as a liaison on regulatory issues between the Cook Manufacturer and the Cook International local office and/or Cook distribution partner.
Maintains and organises appropriate regulatory records to demonstrate compliance with applicable regulations.
Performs additional duties as assigned.
Ensure that Cook's Code of Conduct is considered in all business matters carried out on Cook's behalf.
Delegate for the Regulatory Communications Team Lead.
Qualifications Third level Qualification in Science/Engineering desired.
A number of years experience in a regulated industry in a similar role required.
Thorough knowledge of the EU & US medical device regulatory requirements.
Knowledge of regulatory requirements in MDSAP countries.
Desirable to have knowledge of requirements in other jurisdictions.
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 Office.
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.
-
Regulatory Communications Specialist
3 weeks ago
Limerick, Limerick, Ireland Cook Medical Full timeOverview The Regulatory Communications Specialist serves as a communication liaison between the Cook manufacturer and the Cook local affiliates or regulatory authorities and assists in assessing complaints for Regulatory Reporting, this includes Adverse Event Reporting (MDR, Vigilance, etc.), Post Market Surveillance Activities (PMS), field action and...
-
Regulatory Compliance Coordinator
2 weeks ago
Limerick, Limerick, Ireland beBeeregulatory Full time €50,000 - €70,000Job Summary">We are seeking a highly skilled Regulatory Communications Specialist to serve as a key liaison between our organization and regulatory authorities. This role involves assessing complaints, generating reports, and ensuring compliance with applicable regulations.
-
Medical Device Regulatory Liaison
7 days ago
Limerick, Limerick, Ireland beBeeRegulatory Full time €55,000 - €70,000Regulatory Communications Specialist Overview The Regulatory Communications Specialist plays a key role as a communication liaison between manufacturers and regulatory authorities. This position is responsible for assessing complaints to determine if they meet reporting requirements, generating regulatory reports, and liaising with regulators. Key...
-
Strategic Liaison for Regulatory Compliance
2 weeks ago
Limerick, Limerick, Ireland beBeeMedicalDeviceRegulation Full time €68,030 - €85,550Regulatory Communications Specialist Overview The Regulatory Communications Specialist acts as a communication conduit between manufacturers and local affiliates or regulatory authorities. This role involves assessing complaints for Regulatory Reporting, including Adverse Event Reporting (MDR, Vigilance, etc.), Post Market Surveillance Activities (PMS),...
-
Medical Device Regulatory Specialist
1 week ago
Limerick, Limerick, Ireland beBeeCompliance Full time €45,000 - €65,000Regulatory Compliance ExpertWe are seeking a highly skilled Regulatory Compliance Expert to join our team. As a key member of our organization, you will serve as a liaison between our manufacturer and local affiliates or regulatory authorities.Your primary responsibility will be to assess complaints from global customer support and delivery centres to...
-
Supply Chain Planning Specialist
2 weeks ago
Limerick, Limerick, Ireland Verizon Communications Full timeApply prior to the end date: September 30th, 2025When you join VerizonYou want more out of a career.A place to share your ideas freely — even if they're daring or different.Where the true you can learn, grow, and thrive.At Verizon, we power and empower how people live, work and play by connecting them to what brings them joy.We do what we love — driving...
-
Supply Chain Planning Specialist
3 weeks ago
Limerick, Limerick, Ireland Verizon Communications Full timeApply prior to the end date: September 30th, 2025When you join VerizonYou want more out of a career. A place to share your ideas freely — even if they're daring or different. Where the true you can learn, grow, and thrive. At Verizon, we power and empower how people live, work and play by connecting them to what brings them joy. We do what we love —...
-
Senior Regulatory Reporting Specialist
6 days ago
Limerick, Limerick, Ireland beBeeRegulatory Full time €60,000 - €100,000Effective regulatory reporting is crucial for the financial services industry.Key Responsibilities:Plan and execute daily and periodic regulatory reportingEvaluate proposed regulation changes with internal departmentsCollaborate with regulators, relationship managers, and clients on existing reporting solutionsCross-train partners across EMEA and outsourced...
-
Project Lead
5 days ago
Limerick, Limerick, Ireland beBeeBiopharmaceutical Full time €45,000 - €60,000Project Engineer - Biopharmaceutical ExpertThe position of Project Engineer - Biopharmaceutical Expert is pivotal to ensuring seamless communication and collaboration between client stakeholders and our Global Facility Delivery team in a highly regulated environment. The successful candidate will be responsible for orchestrating effective communication,...
-
Supply Chain Specialist
4 weeks ago
Limerick, Limerick, Ireland Verizon Communications Full timeWhen you join VerizonYou want more out of a career.A place to share your ideas freely — even if they're daring or different.Where the true you can learn, grow, and thrive.At Verizon, we power and empower how people live, work and play by connecting them to what brings them joy.We do what we love — driving innovation, creativity, and impact in the...