COMPANY OVERVIEW

Ultimate Wireforms, Inc. is a leader in dental manufacturing, dedicated to producing high-quality dental products that meet the needs of dental professionals. Our commitment to excellence and innovation drives our operations, ensuring we provide the best solutions for our clients.

SUMMARY

The Regulatory Assistant is responsible for clerical support of the Quality and Regulatory Department by maintaining documentation systems, assisting with audits and management reviews, facilitating training tasks, and aiding document control and regulatory functions. The ideal candidate will play a crucial role in ensuring compliance, accuracy in documentation, and the smooth execution of quality-related processes.

STANDARDS AND DIRECTIVES MANAGEMENT: UNDER THE GUIDANCE OF THE COMPLIANCE ADMINISTRATOR, ASSIST IN MAINTAINING THE REQUIREMENTS OF QUA-020 (STANDARDS AND DIRECTIVES PROCESS). THIS TASK INCLUDES THE ORGANIZATION OF STANDARDS AND DIRECTIVES, ENSURING COMPLIANCE WITH REGULATORY REQUIREMENTS AND INTERNAL POLICIES AS STATED BELOW:

• Maintain up-to-date internal copies of all applicable Standards and Directives.

QUALIFICATIONS:

• High school diploma or equivalent required; associate or bachelor’s degree preferred.
• Minimum 2 years of administrative experience, preferably in a regulated or quality-focused environment.
• Strong organizational skills and attention to detail.
• Proficient in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint).
• Ability to handle confidential and sensitive information with discretion.
• Excellent communication skills - written and verbal.
• Familiarity with document control systems, OMS concepts, and internal auditing a plus.
• Must be good and excellent people skills. Will need to effectively communicate both verbal and written with all levels of the organization.
• Have ability to manage multiple priorities and multitask.
  Job Type: Part-time
  Pay: $20.00 - $25.00 per hour
  Work Location: In perso

RESPONSIBILITIES

• The Regulatory Assistant shall assist with all processes related to Document Change Control under the guidance of the Compliance Administrator. This includes modification and receiving the approval of document changes while ensuring all changes are accurately recorded and communicated.

This responsibility includes the follow-up tasks:

• Track and follow-up on document change approvals pending authorization.
• Track re-training progress and report to the Compliance Administrator when re-training is overdue.

CUSTOMER SUPPORT: PROVIDE EXCEPTIONAL SUPPORT TO CUSTOMERS, ADDRESS INQUIRIES PROMPTLY WITH THE GOAL OF PROVIDING ACCURATE DATA IN A TIMELY MANNER. PER THE ASSIGNED TASKS OF THE COMPLIANCE ADMINISTRATOR, WE MUST WORK TO ENSURE OUR CUSTOMER REQUESTS ARE PROCESS IN A TIMELY MANNER.

• Provide customers with requested QMS Certificates and Technical Documents.
• Log customer activity per QMS requirements.
• Complete and submit approved Supplier Questionnaires as required.
• Log and track all customer requests, ensuring timely resolution.

TRAINING & RE-TRAINING TASKS:

· Collect training folders from new employees after two months of employment.

• Maintain and update the employee training matrix.
• File training folders and verify completion of training sessions.
• Update the matrix with re-training dates and maintain verification forms per STD DOC 143 (QRM).
• Follow up on trainers regarding incomplete re-training and maintain accurate records. Notify the Compliance Administrator of any delinquent training.
• Audit Support:
• Serve as an internal auditor upon completion of training.
• Issue audit schedules and post them to Quality Boards.
• Schedule audit meetings and notify team members of upcoming audits.
• Provide reminders for any outstanding audit activities.

REGULATORY AND GENERAL ADMINISTRATIVE SUPPORT: HELP IN NAVIGATING REGULATORY REQUIREMENTS AND PERFORMING GENERAL ADMINISTRATIVE TASKS TO ENHANCE OPERATIONAL EFFICIENCY AND COMPLIANCE THROUGHOUT THE ORGANIZATION.

• Assist in renewing subscriptions (e.g., ASQ, ADA, FDA News, RAPS).
• Monitor and update the Substances of Very High Concern (SVHC) list biannually.
• Conduct monthly reviews of safety-related incidents via designated websites.
• Fulfill co-worker requests related to Regulatory documentation, such as printing Hold Sheets.
• Support the transition of key records (e.g., Supplier Files, Internal Audits, CARs) to electronic format by scanning and saving documents within the Quality System.

ADDITIONAL RESPONSIBILITIES:

• Any additional responsibilities, duties or projects assigned by the Compliance Administrator and/or Director of Regulatory and Purchasing.
• The Regulatory Assistant – Quality & Regulatory Support shall continually look for system improvements and for means of streamlining Quality System processes.

You are an integral part of the Ultimate team, reporting directly to the Director of Regulatory and Purchasing. It is extremely important that all the responsibilities outlined above are performed with the intent in mind of:

• adhering to moral and ethical standards in dealing with coworkers, subcontractors, customers, suppliers and visitors.
• the safety, health and welfare of our coworkers and customers.
• providing our customers with the best possible products at the fairest possible prices.
• providing our customers with the absolute best possible customer service within the current, time-tested strategy we have maintained over the years.
• fostering a work environment throughout UWI and UdB that is pleasant, supportive, cooperative and complying with ethical standards and state and federal guidelines.
• always looking to improve whenever possible, cut costs, eliminate redundancy, streamline and ultimately improve profits and.
• Growing UWI in both sales and profits.