Regulatory Communications Specialist

• 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 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.

• 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.

Cook Group