Regulatory Communications Specialist

3 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 associated correspondence to applicable Regulatory bodies.
Reporting to: Regulatory Communications Team Lead 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.
Responsibility for implementing applicable regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA QSP 21 CFR 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 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.
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