Post Market Surveillance Specialist 1

3 weeks ago

Limerick, Ireland Cook Medical Incorporated Full time

Overview

The Post Market Surveillance 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 associated correspondence to applicable Regulatory bodies.

Reporting to: Team Lead, Post Market Survelliance

Find out more about Cook Medical here

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.
- Knowledge of relevant ISO, EU, FDA medical device standards regulations is 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.

#J-18808-Ljbffr

  • Post Market Surveillance Specialist 1

    3 weeks ago

    Limerick, Ireland Cook Medical Full time

    Overview The Post Market Surveillance 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...

  • Post Market Surveillance Specialist 1

    2 weeks ago

    Limerick, Ireland Cook Medical Incorporated Full time

    OverviewThe Post Market Surveillance 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 Communications Specialist

    3 weeks ago

    Limerick, Ireland Cook Medical Full time

    Overview 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 Communications Specialist

    3 weeks ago

    Limerick, Ireland Cook Medical Incorporated Full time

    OverviewThe 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...

  • Apply in 3 Minutes! Regulatory Communications Specialist

    3 weeks ago

    Limerick, Ireland Cook Medical Incorporated Full time

    Overview 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 Communications Specialist

    4 weeks ago

    Limerick, Limerick, Ireland Cook Medical Full time

    Overview 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...

  • Job Posting Title Registered Nurse

    3 weeks ago

    Limerick, Ireland Fresenius Medical Care Full time

    OverviewRegistered Nurse - Renal Dialysis UnitThis post is eligible for a Welcome Bonus of €2,500* (taxable) for successful candidates, split into 2 instalments, one at passing probation (6 months) and the next at 18 months in post (pro rata if applicable).Alternatively we can offer relocation packages* for those looking to relocate to Limerick and the...

  • Tender Representative 1

    4 weeks ago

    Limerick, Limerick, Ireland Cook Medical Full time

    OverviewJoin to apply for the Tender Representative 1 role at Cook Medical.The Tender Representative 1 is responsible for working with Cook Medical Divisions & other relevant departments within Cook Medical, to ensure that Tenders to supply Cook Medical products to the European Market are submitted in a timely and accurate manner. This role is also...

  • Clinical Midwife Manager 1

    4 weeks ago

    Limerick, Limerick, Ireland Hse Mid West Full time

    OverviewThere is currently a permanent, whole-time vacancy available in University Maternity Hospital Limerick.A panel may be formed as a result of this campaign for Clinical Midwife Manager 1 from which current and future, permanent and specified purpose vacancies of full or part-time duration may be filled.PositionBainisteoir Cnáimhseach Cliniciúil...

  • Customer Support Representative 1 with Italian

    4 weeks ago

    Limerick, Limerick, Ireland Cook Medical Full time

    Customer Support Representative 1 with ItalianJoin to apply for the Customer Support Representative 1 with Italian role at Cook MedicalCustomer Support Representative 1 with ItalianJoin to apply for the Customer Support Representative 1 with Italian role at Cook MedicalGet AI-powered advice on this job and more exclusive features.The Customer Support...