Regulatory Compliance Expert
We are seeking a highly skilled Regulatory Compliance Expert to join our team. As a key member of our organization, you will serve as a liaison between our manufacturer and local affiliates or regulatory authorities.
Your primary responsibility will be to assess complaints from global customer support and delivery centres to determine if events meet regulatory reporting requirements. You will utilize complaint software systems for processing complaints and generate appropriate regulatory reports based on assessment.
You will liaise effectively with regulators on all issues related to regulatory reporting and ensure that confirmed reportable events are escalated to the appropriate personnel in a timely manner.
Additional responsibilities include communicating with other companies globally as necessary for reporting, generating responses to inquiries on AE reports from various global regulatory authorities, and maintaining an excellent understanding of global medical device regulations.
Furthermore, you will be responsible for implementing applicable regulatory requirements in accordance with ISO 13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745, and FDA QSR 21 CFR Part 820.
Key Responsibilities:
* Assessing complaints from global customer support and delivery centres
* Liaising with regulators on regulatory reporting
* Generating regulatory reports based on assessment
* Maintaining knowledge of global medical device regulations
* Implementing regulatory requirements in accordance with relevant standards
Required Skills and Qualifications:
* Third-level qualification in Science/Engineering desirable
* A number of years experience in a regulated industry in a similar role required
* Thorough knowledge of EU & US medical device regulatory requirements
* Knowledge of regulatory requirements in MDSAP countries
* 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