We are actively seeking to recruit a Regulatory Communications Specialist to serve as a communication liaison between the manufacturer and the local affiliates or regulatory authorities of a leading Medical Device multinational. The successful candidate will assist 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
· 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.
· Ensuring 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.
· Close out of complaints as necessary.
· Input and adherence to the scheduling and management of Post Market Surveillance (PMS) plans and reports.
· 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.
Maintains and organises appropriate regulatory records to demonstrate compliance with applicable regulations.
Qualifications / 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.
· 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.