Post Market Surveillance Specialist 1

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, , Post Market Surveillance Activities (PMS), field action and associated correspondence to applicable Regulatory bodies.Reporting to: Team Lead, Post Market Surveillance Department Complaints Responsibilities Department ComplaintsAssess 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 21CFR 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 Department ComplaintsThird level Qualification in Science/Engineering desired.Experience in a regulated industry in a similar role is beneficial.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. Our employee benefits include: Hybrid Work Model Company sponsored Defined Contribution pension schemeMedical 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 talksFully equipped gym on site 39-hour week with flexible start & finish times Paid time off to participate in volunteer activitiesFree parking Subsidised restaurant Sports & Social club#LI-Hybrid