Regulatory Staffing - Analyst

First Quality • Lewistown, PA

20h • Onsite

About The Position

First Quality Enterprises, LLC is seeking a Regulatory Affairs Analyst to provide regulatory support and guidance to Absorbent Hygiene project teams, Product Development, and legal counsel. The role helps establish and submit product and material technical data used to evaluate compliance with domestic and international requirements, including ingredient safety and efficacy, product development compliance, customer and regulatory needs, and consumer regulatory inquiries.

The analyst maintains knowledge of regulations and emerging legislation affecting consumer products, particularly absorbent hygiene medical devices and cosmetics, with an emphasis on product safety and chemicals of concern. The role evaluates product and packaging safety, supports compliant product and packaging design, collaborates on safety testing and certifications, maintains regulatory-system information, and reviews product labeling, claims, and training materials. The position is based in Lewistown, Pennsylvania, and may require travel for audits and regulatory, industry, or customer meetings and events.

Requirements

• At least 3 years of regulatory experience; experience in quality assurance, research and development/support, scientific affairs, operations, or a related area may also be considered.
• Experience applying knowledge of product development processes and product lifecycle management.
• Project management experience, including monitoring and measuring results.
• Understanding of laboratories and test reports, including hands-on experience working with certification agencies.
• Knowledge of applicable federal, state, and international regulations.
• Ability to inform and educate managers and department heads about regulations and policies requiring compliance.
• Ability to review technical documents and influence colleagues across functions.
• Ability to operate cross-functionally and follow up to obtain answers.
• Excellent written and verbal communication skills.
• Excellent analytical and problem-solving skills.
• Excellent strategic planning skills.
• Proficiency with applicable database and compliance software.
• Proficiency with Microsoft Office Suite or similar software.

Nice To Haves

• Bachelor’s degree in chemistry, toxicology, environmental science, engineering, or a related field.
• Education or experience in material science or engineering.
• Lead Auditor Certification, preferably ISO 9001:2015, ISO 22716:2007, or ISO 13485:2016.

Responsibilities

• Maintain current knowledge of regulations and emerging legislation applicable to consumer products, particularly absorbent hygiene medical devices and cosmetics, with a focus on product safety and chemicals of concern.
• Stay familiar with applicable regulatory standards and customer requirements related to product safety and chemicals of concern.
• Evaluate product and packaging safety, identify potential hazards, and ensure compliance with local, state, and federal requirements.
• Maintain knowledge of products, chemistries, and manufacturing processes.
• Work proactively with Product Development and cross-functional teams to improve safety standards, address compliance concerns, and support safe, compliant product and packaging designs.
• Manage and collaborate with Product Development on product safety testing processes, certification requirements, and related documentation.
• Support the use of regulatory systems and the development and maintenance of supporting information for reporting.
• Review and advise on labeling, product claims, and training materials related to product safety and chemicals of concern.
• Travel as required for audits or regulatory, industry, and customer meetings and events.

Benefits

• Competitive base salary and bonus opportunities
• Paid time off (three-week minimum)
• Medical, dental, and vision coverage starting day one
• 401(k) with employer match
• Paid parental leave
• Child and family care assistance through a dependent care FSA with employer match up to $2,500
• Bundle of joy benefit: years’ worth of free diapers for team members with a new baby
• Tuition assistance
• Wellness program with savings of up to $4,000 per year on insurance premiums

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level