Regulatory Compliance Specialist
We are seeking a diligent and organized individual to fill the role of Regulatory Compliance Specialist on a contract basis.
* Provide administrative support in an office setting, ensuring compliance with regulatory requirements.
* Assist regulatory staff with document management and tracking.
* Set up and maintain files, prepare reports, and take minutes during team meetings.
* Perform data entry, proofread, and compile reports.
* Manage the inbox and coordinate outgoing mail.
The ideal candidate will have a degree qualification in a relevant Science or Engineering discipline and 1+ years' experience working in a Quality Assurance regulated medical product environment. Strong knowledge of FDA 21 CFR820, ISO 13485, IVDD98/79/EC, and international regulatory requirements is essential.
Key skills include:
* In-depth understanding of regulatory frameworks.
* Excellent communication and interpersonal skills.
* Attention to detail and task prioritization.
Responsibilities:
* Comply with regulatory guidelines.
* Maintain accurate records.
* Prepare reports and documents.
Requirements:
* Bachelor's degree in a relevant field.
* Experience in Quality Assurance.
* Strong knowledge of regulatory standards.