Administrative Support Specialist

7 days ago

Killaloe, Clare, Ireland beBeeRegulatory Full time €40,000 - €60,000

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.

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