Regulatory Staffing - Analyst

First Quality • Lewistown, PA

12d • 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, emerging legislation, applicable standards, and customer requirements related to consumer products, especially absorbent hygiene medical devices and cosmetics, with a focus on product safety and chemicals of concern. The role evaluates product and packaging safety, identifies potential hazards, supports testing and certification processes, and works with cross-functional teams to address compliance concerns and improve safe product and packaging designs. It also supports regulatory systems and records and reviews labeling, product claims, and training materials related to product safety and chemicals of concern.

The position is based in Lewistown, Pennsylvania, and requires travel as needed for audits and regulatory, industry, or customer meetings and events.

Requirements

• Minimum 3 years of experience in regulatory affairs; candidates with experience in quality assurance, research and development or support, scientific affairs, operations, or a related area may also be considered.
• Experience applying knowledge of product development processes and product lifecycle management.
• Experience in project management and monitoring and measuring results.
• Experience with laboratories and test reports, including hands-on work 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 work cross-functionally and obtain needed information.
• 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 in ISO 9001:2015, ISO 22716:2007, or ISO 13485:2016.

Responsibilities

• Maintain current knowledge of regulations and emerging legislation applicable to consumer products, primarily 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 pertaining 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 thorough knowledge of products, chemistries, and manufacturing processes.
• Work proactively with Product Development and cross-functional teams to maintain and improve safety standards and address compliance concerns in product and packaging designs.
• 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 information within those systems 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 and regulatory, industry, and customer meetings or 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: a year’s 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