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 are excited to announce an opening for a Regulatory Affairs/Compliance Associate in our Lafayette, CO office.

The Regulatory Affairs/Compliance Associate will be responsible for assisting the Regulatory Affairs/Compliance Lead with 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:

• Assist with 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.
• With support of outside counsel and regulatory consultant support, assist cross-functional health claims adjustment process to establish risk profile for and ensure compliance of product, marketing, and general customer communication.
• Prepare 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.
• Assist with CBD Compliance.
• Assist with FDA submittal when applicable.
• Other RA tasks as required.

Qualifications:

Qualified candidates must have a high school diploma or equivalent and intermediate experience in MS Office Suite. Must have 1 year + regulated industry experience (such as pharmaceutical, medical device, food, dietary supplement, cosmetic, OTC drugs).

Ideal Candidates have the following traits:

• Bachelor of Science degree
• 1-3 years of Regulatory Affairs experience
• Knowledge of FDA food and dietary supplement product regulations (21 CFR 111, 21 CFR 117, DSHEA)
• cGMP experience

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 vacation and sick time.

Paid company holidays.

Fitness Center membership.

Generous employee discount program on all QS products.

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.