**Job Title:** Regulatory Communications Specialist
Job Summary:
The Regulatory Communications Specialist serves as a key liaison between the manufacturer and regulatory authorities, assessing complaints for reporting purposes.
* Assess customer complaints from global support and delivery centres to determine if events meet reporting requirements.
* Utilize complaint software systems for processing and generating reports.
* Liaise with regulators on all issues related to reporting.
* Evaluate confirmed reportable events and escalate them in a timely manner.
Maintain an excellent understanding of medical device regulations and implement applicable requirements. Coordinate multiple projects simultaneously and provide regular updates. Serve as a liaison on regulatory issues between the manufacturer and international offices or distribution partners. Ensure compliance with regulations and perform additional duties as assigned.
Qualifications and Skills:
We are seeking candidates with a third-level qualification in Science/Engineering and several years of experience in a regulated industry. A thorough knowledge of EU & US medical device regulatory requirements is essential, along with knowledge of quality standards and practices in similar industries.
* Good communication and interpersonal skills are required.
* Proven problem-solving skills are necessary.
* Proficiency in Microsoft Office and computer skills are expected.
* Strong organisational skills and high self-motivation are necessary.
Occasional travel on company business may be required. If you have the skills and qualifications we are looking for, please apply.