Regulatory Affairs Specialist III

About the role

VARITE is looking for a qualified Regulatory Affairs Specialist III in Maplewood, MN (Hybrid).

WHAT THE CLIENT DOES?

An American-headquartered life science and clinical research company. It is a global supplier of analytical instruments, clinical development solutions, specialty diagnostics, laboratory, pharmaceutical and biotechnology services.

WHAT WE DO?

Established in the Year 2000, VARITE is an award-winning minority business enterprise providing global consulting & staffing services to Fortune 1000 companies and government agencies. With 850+ global consultants, VARITE is committed to delivering excellence to its customers by leveraging its global experience and expertise in providing comprehensive scientific, engineering, technical, and non-technical staff augmentation and talent acquisition services.

Job Title: Regulatory Affairs Specialist III

Location: Maplewood, MN (Hybrid)

Contract Duration: 18 months (Possible Extension)

Pay Rate Range: $45.00/hr. to $55.00/hr. on W2

Work Authorization: Only USC or GC

Key Responsibilities

• Regulatory Strategy & Compliance: Develop and execute global regulatory strategies that support new product commercialization and lifecycle management. Interpret emerging global regulations and communicate regulatory impacts to business stakeholders. Provide regulatory guidance throughout product development, change management, and product discontinuation activities. Ensure compliance with applicable global chemical, environmental, product safety, and industry-specific regulations. Support regulatory submissions, product registrations, declarations of conformity, and compliance documentation where applicable.
• Product Stewardship: Lead product stewardship activities throughout the entire product lifecycle. Conduct product hazard, exposure, and risk assessments. Evaluate product composition for regulatory compliance and sustainability objectives. Partner with R&D and Product Management to identify regulatory risks early during product development. Develop mitigation strategies that balance regulatory compliance, customer expectations, and business objectives. Support responsible chemical management and sustainable product design initiatives.
• Global Regulatory Compliance: Provide expertise in applicable regulations including, but not limited to: TSCA, REACH, GHS, CLP, RoHS, PFAS, Food Contact, and Hazard Communication requirements. Support FDA and USP requirements, where applicable.
• New Product Introduction (NPI): Participate as the Regulatory Affairs and Product Stewardship representative on global product development teams. Support Stage Gate and design review processes. Review product claims, labels, instructions for use, technical literature, and marketing materials. Ensure regulatory requirements are incorporated into commercialization activities. Evaluate product changes for regulatory impact and coordinate required actions before implementation.
• Cross-Functional Collaboration: Partner closely with: Research & Development, Quality, Manufacturing, Operations, Environmental Health & Safety, Supply Chain, Procurement, Marketing, Sales, Legal, Global Regulatory Affairs to ensure regulatory compliance while supporting business objectives and operational excellence.
• Customer & Commercial Support: Respond to customer regulatory inquiries. Prepare compliance letters, declarations, certificates, and technical documentation. Support customer audits and regulatory assessments. Review customer questionnaires regarding product compliance and chemical content. Partner with Commercial teams to resolve customer regulatory concerns.
• Regulatory Intelligence: Monitor emerging global regulations affecting Client's products and markets. Assess business impact and develop implementation strategies. Communicate regulatory changes to leadership and cross-functional teams. Participate in industry associations and professional organizations to maintain current regulatory knowledge.
• Quality & Risk Management: Support Quality Management Systems including ISO 9001 and ISO 13485 where applicable. Participate in product risk assessments and Failure Mode and Effects Analysis (FMEA) activities. Contribute to continuous improvement initiatives that strengthen compliance and operational effectiveness. Support internal and external audits.

Minimum Qualifications

• Bachelor's degree in Chemistry, Chemical Engineering, Biology, Toxicology, Environmental Science, Materials Science, Life Sciences, Engineering, or another related scientific discipline.
• Minimum five (5) years of experience in Regulatory Affairs, Product Stewardship, Environmental Health & Safety, Product Compliance, Quality, or related technical functions.
• Demonstrated experience supporting global regulatory compliance programs.
• Experience working in cross-functional technical teams.
• Excellent written and verbal communication skills.
• Strong analytical, organizational, and project management skills.
• Ability to manage multiple priorities within a fast-paced global environment.

Preferred Qualifications

• Experience supporting filtration, purification, laboratory, bioprocessing, diagnostics, medical device, pharmaceutical, or chemical products.
• Knowledge of global chemical regulations including TSCA, REACH, GHS, CLP, RoHS, PFAS, Food Contact, and Hazard Communication requirements.
• Experience supporting New Product Introduction (NPI) and product lifecycle management.
• Experience performing product risk assessments and lifecycle evaluations.
• Knowledge of ISO 9001, ISO 13485, and quality management systems.
• Experience preparing Safety Data Sheets (SDS), regulatory declarations, and customer compliance documentation.
• Regulatory Affairs Certification (RAC), Certified Hazardous Materials Manager (CHMM), or other applicable professional certifications.

BENEFITS

We offer a comprehensive benefits package designed to support the health, well-being, and financial security of our employees and their families. Eligible employees may receive:

• Health Insurance: Medical, dental, and vision coverage
• Retirement Plans: Participation in a company-sponsored retirement savings plan
• Legal Service Plans: Offering access to attorneys for legal advice and representation.

If this opportunity interests you, please respond by clicking on EasyApply. Know someone who would be perfect for this role? Refer to us and if they are hired, you could be eligible for our employee referral bonus! Help us grow our team with top talent from your network.

VARITE is committed to creating a diverse environment and is proud to be 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.