Overview

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

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.
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 with labeling and 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 Cook’s products for global markets.

Quality Engineering in Limerick

Our QE team in Limerick is made up of 4 different subgroups: quality engineering, supplier engineering, regulatory communications and complaint investigations.

The quality engineering team are responsible for the CAPA, NCR, NC trending and field action assessments processes. They work cross functionality with operations, engineering, medical affairs and regulatory affairs during the design process and throughout the device lifecycle. They are heavily involved in supporting strategic objectives for the site including IT solutions and continuous improvement efforts.

The supplier quality engineering team are responsible for the qualification, auditing, monitoring and assessment of all new and existing suppliers across this site. This ranges from quality impacting suppliers to non-quality impacting suppliers.

The regulatory communications team are responsible for the regulatory assessment and submitting reports as required for all our device customer complaints. In addition, they are responsible for any field actions which are initiated associated 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 team are responsible for the root cause, evaluation, investigation, risk assessment and corrective action determination of all our device related customer complaints. They are responsible for the 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 they are responsible for different aspects of the product lifecycle which ultimately all feed into one another.  Our Quality Engineering team are central to holding Cook to the highest standards because everything we do has an impact on someone’s life. 

Our employee benefits include:

Hybrid Work Model

Company sponsored Defined Contribution pension scheme

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, nutrition talks

Fully equipped gym on site

39-hour week with flexible start & finish times

Paid time off to participate in volunteer activities

Free parking

Subsidised restaurant

Sports & Social club

#LI-Hybrid

Post Market Surveillance Specialist 1

Benefits

Job Description