Job Title:
Regulatory Affairs Coordinator
About the Role:
We are seeking a detail-oriented and organized Regulatory Affairs Administrator to join our team. As a key member of our regulatory staff, you will be responsible for providing administrative support for filing and tracking of documents.
Key Responsibilities:
* Provide general administrative support in an engineering office setting, including filing and tracking of documents.
* Respond to requests for administrative support from regulatory staff as needed.
* Maintain files, prepare reports, and take minutes during team meetings.
* Perform data entry, proofread, and compile special reports.
* Receive and distribute incoming mail, and coordinate outgoing mail, including courier services.
* Manage the regulatory admin inbox together with other Administrative Associates.
* Schedule meetings and meeting arrangements, and provide meeting support as needed.
* Communicate with internal and external personnel as required.
* Prepare and maintain documentation, plans, reports, schedules, databases, spreadsheets, logs, etc. to support functions.
* Support regulatory staff with submissions to regulatory authorities.
Requirements:
* Bachelor's degree in a relevant Science, Engineering or Quality Assurance discipline.
* At least 1 year's experience working in a Quality Assurance regulated medical product environment is an advantage.
* In-depth knowledge of FDA 21CFR, ISO, IVDD98/79/EC and international regulatory requirements.
* Strong interpersonal skills and ability to communicate well both verbally and in writing.
* Excellent attention to detail and ability to prioritize.