LSI SOLUTIONS founded in 1986, located in beautiful Victor, New York, is a dynamic and growing medical device company with over 500 employees dedicated to advancing minimally invasive surgical instruments through research, development, manufacturing, and marketing. We have doubled in size in just the last 4 years. The LSI Campus includes 10 buildings (170,000+ sq ft) on 95 meticulously cared for acres.
We are searching for passionate people looking to make a difference in the medical device industry. By joining LSI SOLUTIONS an ISO 13485 certified company, you will become part of as energetic team working together to relentlessly pursue better patient outcomes with state-of-the-art devices. After all, our customer is ultimately the patient.
POSITION TITLE: Administrative Assistant
LOCATION: Onsite at LSI Solutions in Victor, NY
HOURLY PAY RANGE: $24.21/hr - $33.00/hr.
SHIFT HOURS: Days (Monday to Friday 8am to 5pm)
LOCATION: Onsite at LSI Solutions in Victor, NY
JOB SUMMARY: This position will provide administrative and clerical support to the Executive Director of Regulatory Affairs and Quality.
ESSENTIAL FUNCTIONS:
Administrative Assistant I
• Create and maintain planning tools such as executive, monthly, annual, and team vacation calendars.
• Create and maintain focus maps in MS Excel with frequent coaching.
• Make arrangements for off-site meetings.
• Proactively establish an agenda for the monthly Regulatory Leadership meetings.
• Create and maintain organizational charts.
• Generate flow charts as requested. Prepare professional looking reports and graphs.
• Manage and maintain executive schedules, including scheduling travel and conferences, making appointments, and making changes to appointments.
• Proactively keep Director being supported organized - where nothing falls through the cracks.
• Sign up Regulatory and Quality staff for offsite and online training.
• Provide some administrative support for Regulatory and Quality directors.
• Organize interviews (phone and on-site) for Regulatory, Quality, and IP candidates.
• Collect and organize presentation content for Quality Objective meetings with coaching.
• Record action items and meeting minutes for the Management Review meeting.
• Prepare invoices, check and reimbursement requests, purchase orders, and credit purchase authorizations for signature and review with coaching.
• Type memos, correspondence, reports, and other documents.
• Maintain established electronic and paper-based filing systems.
• Create and track pre-audit action item checklists with coaching.
• Create LSI-format audit schedules based on auditor agendas, coordinating all facility, IT, and support staff as needed.
• Anticipate office supply needs; place and often expedite orders when necessary.
• Maintain attendance binder for use in fire-drills and building evacuation scenarios.
• Maintain Instructions for Use (IFU) Binders for Executive Director.
• Maintain Notified Body, Competent Authority, and other important regulatory correspondence and reports in a readily accessible and organized electronic format.
• Understand LSI File Structures and relevant QMS procedures.
• Greet guests in a professional, friendly, hospitable manner.
• Perform a variety of clerical duties.
• Professionally handle incoming calls as necessary.
• Organize Team Building Exercises and meals for lunch meetings.
Administrative Assistant II
• All essential functions listed above.
• Create and maintain focus maps in MS Excel with minimal coaching.
• Collect and organize content for Quality Objective meetings independently.
• Collect and organize presentation content for Management Review meetings with coaching.
• Independently prepare invoices, check and reimbursement requests, purchase orders, and credit purchase authorizations for signature and review.
• Maintain administrative knowledge by attending professional and technical educational seminars and workshops; review publications, and participate in relevant professional development organizations.
• Ensure meetings begin on-time, with prep materials delivered in advanced.
• Identify and filter distractions for Executive Director in order to prevent working in a reactive mode.
• Proactively establish an agenda and slides for Quarterly Regulatory Team meetings.
• Proactively establish an agenda for the semi-annual Quality Leadership meeting.
• Proactively establish an agenda for the Monthly DEKRA meeting.
• Ensure all meetings have an agenda, even for standing 1-on-1 meetings.
• Independently Generate DCRs as needed.
Administrative Assistant III
• All essential functions listed above.
• Create and maintain audit project plans.
• Independently create and maintain focus maps in MS Excel.
• Independently collect and organize presentations for Management Review meetings.
• Attend meetings as asked by Executive Director when Executive Director is not able to attend, taking notes, and communicating meeting substance to Executive Director.
• Independently create and track pre-audit action item checklists.
• Recommend changes to established electronic and paper-based filing systems.
• Partner with Executive Director to help maximize efficiency of Executive's time and meeting effectiveness.
• Prepare job requisitions.
• Triage and draft responses to Executive Director's emails.
• Ensure Executive Director's day is planned around tasks that need to be completed.
• Collect and analyze information.
• Handle administrative aspects of new patent application filings and office action responses.
• Prepare and send documents for Apostilling.
• Submission Attachment prep and hyperlinking.
• Review deviation requests (DRs) and rework documentation with direction from Regulatory Leadership.
• Interface, coordinate, and communicate effectively and professionally with Notified Body.
Senior Administrative Assistant
• All essential functions listed above.
• Maintain an audit "Go Bag" with essential, up-to-date information documenting key areas of LSI's QMS for reference and checklists for use in unscheduled audits.
• Create and maintain work instruction regarding the proper recognition, organization, and storage of Notified Body and Competent Authority correspondence.
• Help Executive Director Delegate.
• Handle administrative aspects of IDS filings.
ADDITIONAL RESPONSIBILITIES:
• All other duties as assigned.
EDUCATION & EXPERIENCE:
Administrative Assistant I
• Minimum of 2 years' administrative support experience.
• High School diploma or GED
• Associates and/or bachelor's degree preferred.
Administrative Assistant II
• Minimum of 3 years' administrative support experience.
• 1-2 years' experience relevant to and demonstrating effective performance related to the Administrative Assistant I Essential Functions listed above.
• High School diploma or GED
• Associates and/or bachelor's degree preferred.
Administrative Assistant III
• Minimum of 5 years' administrative support experience.
• 1-2 years' experience relevant to and demonstrating effective performance related to the Administrative Assistant II Essential Functions listed above.
• High School diploma or GED
• Associates and/or bachelor's degree preferred.
Senior Administrative Assistant
• Either 1) a bachelor's degree and least 7 years' administrative support experience and 2 years' experience relevant to and demonstrating effective performance related to the Administrative Assistant III Essential Functions listed above; or 2) a high school diploma, GED, or associates degree and at least 9 years' administrative support experience and 3 years' experience relevant to and demonstrating effective performance related to the Administrative Assistant III Essential Functions listed above.
KNOWLEDGE, SKILLS & ABILITIES:
• Excellent written and verbal communication skills.
• Excellent judgment
• High attention to detail and instructions.
• Trustworthy
• Friendly and professional demeanor.
• Positive, "can-do" attitude; has a sense of challenge.
• Legible handwriting
• Finds the subjects of science, medicine, technology, innovation, and business very interesting.
• Ability to accurately review/proofread documents.
• Ability and willingness to learn new tasks and skills on the job (love of learning.)
• Effective interpersonal skills, whether in-person or on the phone.
• Punctual
• Able to work with minimum supervision.
• Ability to maintain high level of confidentiality of work-related information and materials.
• Ability to keep accurate records and receipts.
• Excellent attention to detail and accurate typing.
• Proven multi-tasker with excellent time management and organization skills.
• Demonstrates flexibility and dedication to work toward time-sensitive deadlines.
• Strong Microsoft Word, Excel, PowerPoint, and Outlook Skills.
• Experience with MS Visio for flow-charting and org-charting, and with MS Project for simple Gannt charting.
• Experience with Microsoft Access and Adobe Acrobat (bookmarking, and hyperlinking) is a plus.
PHYSICAL DEMANDS AND WORK ENVIRONMENT:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job . click apply for full job details
Date Posted: 23 April 2025
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