Job Summary

Serves in an administrative support role to the Regulated Products team (Regulatory Affairs, Clinical Affairs, and Postmarket Surveillance) by performing a wide variety of support functions and office administration duties.

Essential Job Duties and Responsibilities

1. Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
2. Provide administrative support to department staff and leadership.
3. Schedule and support department meetings, including scheduling meeting rooms, confirming internal and external attendees, recording minutes, action items, and key decisions.
4. Assist in planning and organize department events.
5. Maintain department records and databases, including scanning of laboratory notebooks and preparing them for long-term storage.
6. Assist with creating PowerPoint slides and presentations.
7. Manage department master calendar.
8. Order and stock office supplies.
9. Make travel arrangements for the team as needed.
10. Track department spending on purchase card and submit expense reports.
11. Assists with departmental team communication and seating as needed.
12. Provide customer service for visitors and coordinates visits with team as needed.
13. Provide general administrative support for the team as needed, which could include some training on the ERP system.
14. Manage small, low complexity departmental projects and take notes in meetings when necessary.
15. Notarize documents and send for legalization as needed; manage the mailing and receiving of important regulatory documents.
16. Update, organize, and manage regulatory documents and trackers as necessary for OUS registrations.
17. Assist in the management and release of various regulatory documents (i.e. change orders, document revisions, etc.)
18. Reduce compliance risk by ensuring record readiness.
19. Perform other assigned duties or miscellaneous tasks.

Supplemental Data

1. Time management, listening skills, organization and communication are essential to this role.
2. Minimal to no travel required.

Qualifications

Training and Education

Associate’s Degree in office administration preferred or related field, relevant work experience may be substituted for education.

Notary Public certification highly desired.

Experience

Minimum of 2 years’ experience with office administration or relevant experience.

Knowledge, Skills, and Abilities

▪ Excellent time-management skills, organized, and an ability to manage and prioritize multiple low to medium complexity projects, and work assignments from a variety of managers.

▪ Strong interpersonal skills and attention to detail

▪ Excellent verbal and written communication skills

▪ Fantastic customer service, ethics, and high expectations for quality

▪ Intermediate proficiency on basic computer programs: Microsoft Word, Excel, PowerPoint, email, and web searches

Physical Requirements

General physical requirements found in an office setting.