Regulatory and Quality Assurance Project Coordinator

Alma Lasers•Buffalo Grove, IL

3d•Onsite

About The Position

The Regulatory and Quality Assurance Project Coordinator 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
ERP (NetSuite) experience preferred
Experience in the FDA and Health Canada regulated medical device environment is preferred, but not 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
Ability to work on-site in Buffalo Grove, IL (Corporate Office)
Documentation showing eligibility to work in the United States will be required.

Nice To Haves

ERP (NetSuite) experience
Experience in the FDA and Health Canada regulated medical device environment

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.