Regulatory & Quality Specialist

Job Description Quality and Regulatory Specialist Corporate Headquarters485 Half Day Rd. Ste 100Buffalo Grove, IL 60089 Summary 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!Essential FunctionsReasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.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.CompetenciesInitiativeProblem Solving/AnalysisTechnical CapacityOrganizational SkillsCommunication ProficiencyAbility to retain large amounts of information Project Management Education and Experience RequiredBachelor’s degree or equivalent experienceERP (NetSuite) experience preferredExperience in the FDA and Health Canada regulated medical device environment is preferred, but not requiredSkills RequiredPositive attitude and approach to the job responsibilities and the Alma teamMicrosoft Applications (MS Office, Excel, PowerPoint, and Outlook)Excellent organizational skillsEmotional Intelligence Ability to multitask Ability to work on-site in Buffalo Grove, IL (Corporate Office)Supervisory ResponsibilityThis position has no direct reports but assists in mentoring peers and other departments as needed. Work EnvironmentThis 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 DemandsThe 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. TravelThis position requires 0% travel as needed. Work AuthorizationDocumentation showing eligibility to work in the United States will be required. Other DutiesPlease 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.

Salary : $70,000 - $75,000