Quality and Regulatory Specialist
Salary undisclosed
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Job Description
Quality and Regulatory Specialist
This position is full-time and on-site at our Corporate Headquarters in Buffalo Grove, IL
Corporate Headquarters
485 Half Day Rd. Ste 100
Buffalo 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 Functions
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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 no more than 10% travel, as needed.
Work Authorization
Documentation showing eligibility to work in the United States will be required.
Substitute
If the employee is not available, the manager will be the responsible party.
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.
PI262128777
Quality and Regulatory Specialist
This position is full-time and on-site at our Corporate Headquarters in Buffalo Grove, IL
Corporate Headquarters
485 Half Day Rd. Ste 100
Buffalo 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 Functions
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Coordinate and collaborate with internal departments for complaint investigation.
- Regulatory /Competitive Intelligence (Standards, guidance, and state regulations for Cosmetics and devices)
- MoCra, state registrations, Clinicaltrials.gov, keeping up to date with changes to regulations
- 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
- Initiative
- Problem Solving/Analysis
- Technical Capacity
- Organizational Skills
- Communication Proficiency
- Ability to retain large amounts of information
- Project Management
- 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)
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 no more than 10% travel, as needed.
Work Authorization
Documentation showing eligibility to work in the United States will be required.
Substitute
If the employee is not available, the manager will be the responsible party.
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.
PI262128777