International QA/RA Associate - Louisville - Quicksilver Scientific

Description

Join Our Team as an International QA/RA Associate.

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.

What You'll Do as an International RA/QA Associate:

Regulatory Affairs - International

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.

Documentation & Certificates Management

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.

Import / Export Compliance

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.

Quality Assurance Support

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.

Who You Are

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.

Preferred Qualifications

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.

Work Environment & Schedule

Full-time, salary/exempt position.

Monday-Friday, 8:30am-5:00pm with flexibility as business needs require.

Hybrid schedule available.

Why You'll Love Working Here

At Quicksilver Scientific, we're committed to supporting the health, well-being, and professional growth of our team. We offer a comprehensive benefits package that includes:

Medical, Dental, and Vision Insurance

Health Savings Account (HSA) & Flexible Spending Account (FSA) options

Company Paid Life, Short-Term & Long-Term Disability Insurance

401(k) with up to 4% Company Match

Four (4) weeks Paid Time Off

Gym Membership Reimbursement

Compensation: $63,000 to $67,000

About Quicksilver Scientific

At Quicksilver Scientific, we believe in transforming health through science and innovation. Our mission is to help people live healthier, more vibrant lives with natural medicine that works. We are proud to foster a diverse, inclusive, and collaborative workplace.

Ready to make a global impact? Apply today and join a team where your expertise truly matters.

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.