What are the responsibilities and job description for the Regulatory Compliance Manager position at EKS Solutions?
Benefits:
- Competitive salary
- Opportunity for advancement
- Training & development
Ensure regulatory compliance and facilitate market expansion by managing certifications and submissions to domestic and international agencies. Provide expertise in FDA, EU, COSMOS, and RSPO standards, oversee audits, and maintain up-to-date knowledge of regulatory changes.
Responsibilities include but not limited to:
- Develop and maintain systems, policies, and procedures for regulatory compliance with FDA, EU cosmetic regulations, ECOCERT COSMOS-standard Organic and Natural standards, and RSPO standards.
- Prepare renewal and inspection documentation; coordinate on-site or remote audits for regulatory and third-party certifications (COSMOS, RSPO, FDA, etc.).
- Stay updated on changes to laws, regulations, and industry standards; provide guidance on regulatory interpretations and potential impacts on operations, product formulations, claims, and packaging compliance.
- Organize and prepare submissions to certifiers and regulatory bodies to support new product development and market expansion.
- Review raw material documentation for ongoing compliance, new market entry, and emerging regulations.
- Provide technical expertise and risk assessments for product development, labeling, and regulatory issues.
- Prepare ingredient listings (ILS) for US and international markets based on vendor data.
- Conduct regulatory reviews of product labeling for new products and revisions to ensure compliance with US and global regulations, including Prop 65, COSMOS, and RSPO.
- Coordinate updates to product labeling and communicate changes to the Graphic Design team through change control protocols.
- Initiate, review, and maintain Change Control documentation to ensure protocol compliance.
- Compile product dossiers with raw material, component, and formula specifications, and required label information, including directions, warnings, ingredients, allergen information, and marketing materials.
Qualifications:
- Experience with FDA and EU regulatory requirements.
- Knowledge of COSMOS and RSPO standards preferred.
- Strong organizational and communication skills.
- Ability to manage audits and regulatory submissions effectively.
- Detail-oriented with a proactive approach to regulatory compliance.
Working Hours:
- 7:30 AM - 5:00 PM Monday through Thursday
- 8:00 AM - 12:00 PM Friday; Hours may vary based on business needs