International QA/RA Associate

Quicksilver Scientific, Inc•Louisville, CO

26d•$63,000 - $67,000•Hybrid

About The Position

We're seeking a detail-oriented and globally minded International Regulatory Affairs & Quality Assurance (RA/QA) Associate to support our growing international business. This role plays a critical part in ensuring regulatory compliance across global markets while partnering closely with internal teams and international distributors. If you thrive in a fast-paced, regulated environment and enjoy navigating complex global regulations, this is an exciting opportunity to make an impact at a mission-driven company.

Requirements

Bachelor's degree in a related field.
3+ years of QA/RA experience within the nutraceutical or dietary supplement industry.
Experience working in a cGMP-regulated environment.
Working knowledge of FDA food and dietary supplement regulations (21 CFR 111, 21 CFR 117, DSHEA).
Strong attention to detail with excellent documentation and organizational skills.
Ability to interpret and apply international regulatory requirements accurately.
Comfortable managing multiple projects and shifting priorities in a fast-paced environment.
Strong written and verbal communication skills, including collaboration with international partners.
Proficiency with Microsoft Office and regulatory documentation systems.

Nice To Haves

3+ years of international regulatory affairs experience.
Familiarity with foreign regulatory frameworks (EU, UK, Canada NNHPD, Australia TGA, GCC, LATAM, Asia-Pacific).
Experience with botanical, CBD, peptide, or hormone regulatory environments.
Experience supporting or preparing international product registrations.
Regulatory Affairs Certification (RAC) or similar credential.
Multilingual abilities are a plus.

Responsibilities

Coordinate and prepare regulatory documents, submissions, and registration dossiers for international markets, including establishment registrations, product registrations, renewals, and Certificates of Free Sale.
Review international product labels, claims, and marketing materials to ensure compliance with region-specific regulations (EU, UK, GCC, Canada, Australia, LATAM, Asia-Pacific, and more).
Maintain current knowledge of global regulatory frameworks and emerging regulatory changes affecting dietary supplements, foods, cosmetics, and related product categories.
Interpret international regulatory guidance, standards, and directives, providing clear regulatory direction to internal stakeholders.
Prepare, update, and maintain technical files for global registrations and regulatory audits.
Conduct regulatory pathway assessments for new product launches in foreign markets.
Track submission timelines, approvals, renewals, and regulatory commitments.
Evaluate ingredient acceptability, formulation compliance, and permissible claims based on international regulatory requirements.
Support regulatory assessments related to product changes, formula updates, and labeling revisions.
Prepare comprehensive international documentation packages, including Manufacturer's Declarations, Certificates of Free Sale, GMP/ISO certificates, specifications, ingredient documentation, and test reports.
Provide regulatory and technical documentation to international distributors and partners.
Support compliance with international import/export requirements, including HS codes, EORI numbers, customs documentation, and country-specific clearance requirements.
Assist in resolving regulatory-related customs holds or international shipment delays.
Support quality system processes such as document control, change control, and deviations as they relate to international products.
Participate in cross-functional projects and provide regulatory guidance as needed.