Quicksilver is a pioneer in the natural health industry. Our mission is to deliver on the promise of natural medicine, delivering products that help individuals achieve mind and body health through nature inspired innovation. Our growth is fueled by individuals who share our passion. Currently, we have an opening for a Regulatory Affairs/Compliance Specialist in our Louisville, CO location.
The Regulatory Affairs/Compliance Specialist supports the Regulatory Affairs/Compliance department with ensuring company compliance with all applicable regulations - preparing and maintaining all required documentation, applications and renewal of regulatory licenses, certificates, and permits for domestic and foreign entities, along with any additional regulatory duties as determined.
Core Responsibilities include:
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Maintain and process all product complaints in Excel, including opening and managing investigations pertaining to complaints.
- Maintaining the Vendor/Supplier Program.
- Coordinate the preparation of regulatory documents or submissions, including; establishment registration, product registration, and certificates to foreign and local governments.
- Assist with identifying relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Coordinate cross-functional health claims adjustment process to establish risk profile for and ensure compliance of product, marketing, and general customer communication.
- Prepare and/or maintain technical files as necessary to obtain and sustain product approval, registration, and licenses.
- Participate in project teams as assigned and provide guidance on regulatory matters related to document requirements, regulatory submissions, and maintenance.
- Assist with audits, including internal audits and FDA inspections.
- Assist with CBD Compliance for products within all 50 states and internationally - including state registrations, ensuring label compliance, and that suppliers are compliant with regulations.
- Assist with FDA submittals when applicable.
- Be an active member of the Food Safety Team and help maintain Food Safety Plans.
- Create and revise SOPs as needed.
- Other RA tasks as required.
- Bachelor's degree in a related field
- 3-5 years of Regulatory Affairs experience
- Experience working in a cGMP environment
- Knowledge of FDA food and dietary supplement product regulations (21 CFR 111, 21 CFR 117, DSHEA)
- MS Office Suite - intermediate skill level
Ideal Candidates have the following traits:
- High attention to detail
- Ability to work in a team-oriented environment, follow Standard Operating Procedures, and safety protocols
- Self-starter with ability to take direction and work independently
- Ability to work in a fast-paced, rapidly evolving work and market environment
- Ability to prioritize and balance multiple projects simultaneously
Quicksilver offers a competitive benefits package including:
- Employer paid Medical, Dental and Life insurance, including Short-term and Long-term Disability
- 401(k) with company matching
- Paid Time Off
- Paid company holidays
- Paid Parental Leave
- Fitness Center membership
- Generous employee discount program on all QS products
Compensation: $45,000 to $60,000 per year
Quicksilver Scientific is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
This job posting is in compliance with the Colorado "Equal Pay for Equal Work Act."