Regulatory & Quality Specialist

Alma Lasers • Buffalo Grove, IL

10d • Onsite

About The Position

The Quality and Regulatory 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. This is a deadline driven role, needing strong organizational and time management skills! This position is on-site, and we are looking for good people who want to be a part of the amazing culture here at Alma!

Requirements

• Bachelor’s degree or equivalent experience
• 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
• Ability to work on-site in Buffalo Grove, IL (Corporate Office)

Nice To Haves

• ERP (NetSuite) experience preferred
• Experience in the FDA and Health Canada regulated medical device environment is preferred, but not required

Responsibilities

• Coordinate and collaborate with internal departments for complaint investigation.
• Responsible for Metrics tracking and data collection.
• Develop and support general training/meeting materials, including invitations, agendas, and minutes.
• Compile reports from select QA/Reg databases, Keeping QA/Reg leadership informed of any concerns.
• Support the management of the adverse events and ensure issues are reported accurately.
• Follow-up with project teams for supporting documentation and ensure QA/Regulatory recommendations are provided, as directed by QA/Reg leadership.
• Support the preparation and organization of essential document folders, package trackers, and electronic data upload and entry.
• Provide support for all audit activities to include preparation, conduction, and follow-up.
• Work closely with clinical, sales, customer service, and field service on equipment as it pertains to direct patient care.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees