Regulatory and Quality Specialist

Job Description

Regulatory and Quality Specialist

Salary Range: $70,000-$75,000, commensurate with experience

This position is on-site, full-time, located at our Corporate Headquarters in Buffalo Grove, IL

Corporate Headquarters

485 Half Day Rd. Ste 100

Buffalo Grove, IL 60089

Summary

The primary responsibility of the Regulatory and Quality Specialist works under minimal supervision and is responsible for providing day-to-day coordination of activities that enforce continuous monitoring and improvement of systems, ensure QA / Regulatory milestones and deliverables are met, and assure quality and compliance of the Regulatory and Quality team.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Lead and manage collaboration with internal departments for complaint investigation (Adverse Events, Reportable Events).
• Create and review customer follow-up and closing letters pertaining to adverse events.
• Responsible for tracking and trending metrics and data collection for Management Review, Post-Market Surveillance, and general process improvement.
• Assists with tracking Import/Export and Registration listings.
• Develop and support general training/meeting materials, including invitations, agendas, and minutes.
• Training administrator for all new hires.
• Utilize and create job aids to assist with new hire training.
• Regulatory Intelligence - compile reports from select QA/RA databases, keeping QA/Reg leadership informed of any concerns.
• Review and manage marketing/clinical material and OMs to ensure compliance with Regulatory agency compliance for accuracy to cleared claims and indications.
• Collaborate with cross-functional departments for the creation, execution, and maintenance of SOPs, Corrective and Preventive Actions (CAPAs), Nonconformances (NCRs), Change Controls, PSURs, and Annual Reports.
• Manage and maintain the preparation and organization of essential document folders, package trackers (Webtrader), and electronic data upload and entry (Box, Monday, Orcanos).
• Participate in 3rd party audit and inspection activities (ISO, FDA, etc.) and internal Quality Audits.
• Work closely with clinical, sales, customer service, and field service on equipment as it pertains to direct patient care.
• Participate in the development of Management Review presentations.
• Supports QMS IT solutions for automated processes (ERP, CRM, etc.).

Competencies

• Initiative
• Problem Solving/Analysis
• Technical Capacity
• Organizational Skills
• Communication Proficiency
• Ability to retain large amounts of information

Education and Experience Required

• Bachelor’s degree or equivalent experience
• Experience in the FDA and Health Canada submissions and audits is required

Skills Required

• Positive attitude and approach to the job responsibilities and the Alma team
• Microsoft Applications (MS Office, Excel, PowerPoint, and Outlook)
• Excellent organizational skills
• Emotional Intelligence
• Ability to multitask
• Travel to and from Canadian Site- Quarterly

Supervisory Responsibility

This position has no direct reports but assists in mentoring peers and other departments as needed.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. You will be working with sensitive patient images.

Physical Demands

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. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.

Travel

This position requires approximately 15% travel as needed, with travel concentrated in Canada.

Work Authorization

Documentation showing eligibility to work in the United States will be required.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Alma, Inc. is Equal Opportunity Employment:

We're proud to be an equal opportunity employer and celebrate our employees' differences, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or Veteran status.

E-Verification:

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

REQUIREMENTS

Education and Experience Required

• Bachelor’s degree or equivalent experience
• Experience in the FDA and Health Canada submissions and audits is required

Skills Required

• Positive attitude and approach to the job responsibilities and the Alma team
• Microsoft Applications (MS Office, Excel, PowerPoint, and Outlook)
• Excellent organizational skills
• Emotional Intelligence
• Ability to multitask
• Travel to and from Canadian Site- Quarterly