Post Market Surveillance Specialist 1

The Post Market 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 Surveillance

Find out more about Cook Medical here

• 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 Cooks Code of Conduct is considered in all business matters carried out on Cooks behalf.
• Delegate for the Regulatory Communications Team Lead.

• Third level Qualification in Science/Engineering desired.
• Experience in a regulated industry ( ideally minimum 1 years) in a similar role is 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.

About Cook Limerick

Cook Medical has been in Limerick since 1996 starting out withlabelingand distribution and steadily growing and evolving to include manufacturing centralised customer support and on to collaborative product development in the Innovation Centre. The Ireland location is our European headquarters and houses our EMEA Support Centre. This location currently employs more than 1000 people and manufactures 10% of Cooks products for global markets.

Quality Engineeringin Limerick

OurQEteam in Limerickis made up of 4 differentsubgroups: quality engineering supplier engineering regulatorycommunicationsand complaint investigations.

The quality engineering teamare responsible forthe CAPA NCR NCtrendingand field action assessments processes. They work cross functionality withoperations engineering medicalaffairsand regulatoryaffairsduring the design process and throughout the device lifecycle.They are heavily involved in supporting strategicobjectivesfor the site including IT solutions and continuous improvement efforts.

The supplier quality engineering teamare responsible forthe qualificationauditingmonitoringand assessment of all new and existing suppliers across this site. This ranges from quality impacting suppliers tonon-qualityimpacting suppliers.

The regulatory communications teamare responsible forthe regulatory assessmentandsubmittingreports asforall our device customer complaints. In addition theyare responsible forany field actions which areinitiatedassociated with Cook Ireland manufactured devices as well as monitoring and implementing changes associated with regulatory intelligence and are a key input into the post market surveillance programme.

The complaint investigations teamare responsible fortheroot cause evaluation investigation riskassessmentand corrective action determination of all ourdevice related customer complaints. Theyare responsible forthe evaluation of any returned medical devices from the field in a biohazard laboratory.The complaint investigation team are also responsible for trending assessments and are a key input into the post market surveillance programme.

Even though these teams are distinctively different in terms of roles and responsibilities they are all intertwined as theyare responsible fordifferent aspectsof the product lifecyclewhichultimately allfeed into one another.OurQuality Engineeringteam are central to holding Cook to the highest standards because everything we do has an impact on someones life.

Our employee benefits include:

• Hybrid Work Model

• Company sponsored Defined Contribution pensionscheme

• Medical Health Insurance cover for you and your immediate family

• Life Assurance and Income Protection cover

• Educational Assistance

• Performance related Bonus

• Extensive health & wellness program including Indian head massages healthy lifestyle seminars mindfulness courses physio sessions flu vaccinations nutritiontalks

• Fully equipped gym on site

• 39-hour week with flexible start & finish times

• Paid time off toparticipatein volunteeractivities

• Free parking

• Subsidised restaurant

• Sports & Social club

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