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Regulatory Staffing - Analyst at First Quality in US PA Lewistown
Job Description
Regulatory Staffing - Analyst
Location: US PA Lewistown
Founded over 35 years ago, First Quality is a family-owned company that has grown from a small business in McElhattan, Pennsylvania into a group of companies, employing over 5,000 team members, while maintaining our family values and entrepreneurial spirit. With corporate offices in New York and Pennsylvania and 8 manufacturing campuses across the U.S. and Canada, the companies within the First Quality group produce high-quality personal care and household products for large retailers and healthcare organizations. Our personal care and household product portfolio includes baby diapers, wipes, feminine pads, paper towels, bath tissue, adult incontinence products, laundry detergents, fabric finishers, and dishwash solutions. In addition, we manufacture certain raw materials and components used in the manufacturing of these products, including flexible print and packaging solutions.
Guided by our values of humility, unity, and integrity, we leverage advanced technology and innovation to drive growth and create new opportunities. At First Quality, you’ll find a collaborative environment focused on continuous learning, professional development, and our mission to Make Things Better®.
We are seeking a Regulatory Staffing - Analyst for our First Quality Enterprises, LLC, working in Lewistown, PA. The Regulatory Affairs Analyst is responsible for providing regulatory support and guidance to Absorbent Hygiene project teams, Product Development, legal counsel, in the establishment and submission of product and material technical data required to evaluate compliance to domestic and international requirements. This includes the safety and efficacy of ingredients, product development compliance, customer and regulatory compliance needs, and consumer regulatory inquiries
Primary responsibilities include:
- Maintains 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.
- Ensures continuing familiarity with all the latest applicable regulatory standards & customer requirements pertaining to product safety and chemicals of concern.
- Evaluate product and packaging safety, identifying potential hazards, and ensuring compliance with local, state and federal requirements.
- Maintains a thorough knowledge of products, chemistries, and manufacturing processes.
- Work proactively with Product Development and other cross-functional teams to maintain and continually improve safety standards and address compliance concerns ensuring safe and compliant product and packaging designs.
- Manage and collaborate with Product Development on product safety testing processes, requirements for certifications and subsequent documentation.
- Supports the use of systems, development, and maintenance of supporting information within regulatory systems for reporting.
- Review and advise on labeling, product claims, training materials related to product safety and chemicals of concern.
The ideal candidate should possess the following:
- Bachelor’s degree in chemistry, Toxicology, Environmental Science, Engineering or related field preferred. Preferred education or experience in material science or engineering.
- Minimum 3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
- Experience using knowledge of product development process and product lifecycle management.
- Experience in project management; experience monitoring and measuring results.
- Experience using understanding of laboratories and test reports, including hands-on experience working with certification agencies.
- Lead Auditor Certification, preference ISO 9001:2015, 22716: 2007, or 13485:2016
- Knowledge of applicable federal, state, and international regulations.
- Ability to inform and educate managers and department heads on regulations and policies that require compliance.
- Must be capable of reviewing technical documents and influencing colleagues across functions.
- Ability to operate cross-functionally and chase down answers.
- Excellent written and verbal communication skills.
- Excellent analytical and problem-solving skills.
- Excellent strategic planning skills.
- Proficient with applicable database and compliance software.
- Proficient with Microsoft Office Suite or similar software.
- Travel, as required for audits or regulatory, industry, and customer meetings/events
What We Offer You
We believe that by continuously improving the quality of our benefits, we can help to raise the quality of life for our team members and their families. At First Quality you will receive:
- Competitive base salary and bonus opportunities
- Paid time off (three-week minimum)
- Medical, dental and vision starting day one
- 401(k) with employer match
- Paid parental leave
- Child and family care assistance (dependent care FSA with employer match up to $2500)
- Bundle of joy benefit (years’ worth of free diapers to all team members with a new baby)
- Tuition assistance
- Wellness program with savings of up to $4,000 per year on insurance premiums
- ...and more!
First Quality is committed to protecting information under the care of First Quality Enterprises commensurate with leading industry standards and applicable regulations. As such, First Quality provides at least annual training regarding data privacy and security to employees who, as a result of their role specifications, may come in to contact with sensitive data.
First Quality is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identification, or protected Veteran status.