The Regulatory Affairs Specialist - Regulatory Communications 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, PMCF, CER) and associated correspondence to applicable Regulatory bodies.
Reporting to:Senior Regulatory Affairs Specialist
Find out more about Cook Medical here
Assess complaints from Cook global distribution centres for adequate information to determine if event meets Regulatory Reporting requirements.
Utilize appropriate complaint software systems for processing complaints to/from distribution 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.
Assist in coordination of Recall / Field Action administration activities between manufacturer and distribution centre.
Reviewing and approving reports and responses as necessary.
Close out of complaints as necessary.
Input and adherence to the scheduling and management of Post Market Surveillance (PMS) plans and reports, Post Market Clinical Follow Up (PMCF) plans and reports and clinical evaluations (CEPs, CERs). Maintains appropriate regulatory records to demonstrate compliance with applicable regulations.
Liase and advise other Cook functional units (Engineering, Divisions, Quality etc) of the relevant requirements for PMS and PMCF and ensures the outputs from the individual functional units meet the applicable regulatory requirements. Review and analysis of data for same.
Maintain an excellent understanding of global medical device regulations.
Responsibility for implementing applicable regulatory requirements in accordance with ISO13485, MDD 93/42/EEC 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.
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®
Proven organisational skills.
Willingness and availability to travel on company business.
About Cook Medical
Since 1963, Cook Medical has been finding solutions to improve the world’s healthcare problems for the patients and doctors we serve. As one of the world’s largest private companies, we have always operated with our patients, customers, employees and communities at our core. We do this, not only because it is good business, but also because we believe that being a good corporate citizen is the right thing to do.
Cook Medical has been in Limerick since 1993. Since opening, we have become a European headquarters for many of Cook’s business functions.
With a global workforce of 12,000, we employ over 850 people in Ireland who bring Endoscopy, Urology and Peripheral Intervention products from conception to commercialisation.
Regulatory in Limerick
Our RA team in Limerick are responsible for global regulation in over 60 countries, managing pre- & post- market regulation for all product classifications and novel devices across EMEA, AMER and APAC.
Working cross functionally with clinical, quality and engineering during the design process and throughout the device lifecycle, RA are involved in a broad range of activities including marketing authorization and submissions, vigilance and adverse event reporting and clinical evaluation. Our Regulatory Affairs 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:
Life Assurance and Income Protection cover
Company sponsored Defined Contribution pension scheme
Medical Health Insurance cover for you and your immediate family
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