Job Description:
The Regulatory Communications Specialist serves as a communication liaison between the manufacturer and local affiliates or regulatory authorities, assisting 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.
Responsibilities:
* Assess complaints from 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.
* Ensure that confirmed reportable events are escalated to the appropriate personnel in a timely manner.
* Communicate with other 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.
* Closed 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.
* Coordinate multiple projects at one time and provides regular reports to regulatory management and others as required.
Requirements:
* 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.
* 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.