Regulatory Affairs Specialist-FDA Food

At our site in Ann Arbor, we are currently looking for a Regulatory Affairs Specialist-FDA Food to be a part of our growing team.

This position is responsible for leading FDA regulatory product compliance reviews for Food Additive, Food Contact, Dietary Supplements, and Cosmetics applications per the requirements of 21 CFR Food and Drugs. This position is responsible for regulatory affairs reviews and formula and data submissions to the US FDA in relation to Food Additive, Food Contact, Dietary Supplements and Cosmetics, including maintaining our food facility registrations.

The FDA Regulatory Affairs Specialist will evaluate and respond to incoming internal and external customer product compliance requests and will also perform regulatory reviews of Wacker product formulas and incoming chemicals. Work with Wacker business team members to ensure compliance to GMP, FDA-CFR, Food Chemicals Codex (FCC), Responsible Care and cosmetic standards and regulations. This position must have familiarity with reading and interpreting government regulations and utilizing government databases.

This position must have familiarity with FDA food safety plans and the Food Safety Modernization Act (FSMA), FDA Food Safety Management System (FSSC) certification as an internal auditor, certification as a Food Safety Preventive Controls Qualified Individual (PCQI) under FDA rule and training in FDA's foreign Supplier Verification Program (FSVP) rule.

Job Responsibilities

FDA Food Contact Project Management and Compliance:

• Responsible for creating and revising Wacker's Food Contact Evaluation letters for customers. Determinations made by reviewing raw material and Wacker formulations. Interface with Wacker QA/QC for review and signoff on Good Manufacturing Practices and quality signoff on food contact evaluation letters.
• Interface with 3rd party consultants for Food Contact Notifications. Provide technical support to 3rd party consultants for product notifications.
• Obtain quotes for outside food contact related legal opinions and consultation. Interface with FDA on product submissions, and track progress of their reviews.
• Handle submissions to third party certification organizations such as NSF International.

FDA Food Additive and Cosmetic project compliance:

• Maintain and update Wacker's Food facility registrations.
• Responsible for ensuring compliance to FDA food additive and cosmetic regulations. Work with the QC/QA Manager, FDA Preventive Controls Qualified Individual & other responsible departments to ensure compliance to FDA regulation requirements, and Cosmetic standards including USP-NF.
• Communicate relevant updates to FDA's Food Safety Modernization Act to applicable Wacker departments.
• Familiarity with Wacker's Food Safety Plans to ensure compliance. Offer guidance on Wacker Sites' Food Safety Plans and provide guidance during FDA site inspections. Familiarity with current GMP for Food Additive and Cosmetics. Participate in Wacker site internal and 3rd party FDA Food Safety compliance audits.
• Familiarity with Food Chemical Codex monographs and general chapters for compliance.

Dietary Supplement FDA regulation compliance:

• Assist sites in providing dietary supplement bulk excipients material certificates of free sale.
• Work with sites and Wacker Chemie to ensure label compliance to regulations.
• Provide advice on the regulatory requirements that apply to new dietary ingredients.

Document Control:

• Ensure FDA compliance records are organized and maintained.
• Conduct internal compliance review to ensure FDA compliance letters, and supporting information are valid and up to date and reissued within the designated internal review cycle.

Job Qualifications

• Bachelor of Science Degree in Biology, Chemistry, Toxicology, or Food Science. Master's degree is preferred.
• 5+ years' experience
• Strong organizational and professional skills with extensive knowledge of FDA regulations and reading and interpreting legal documents.
• Knowledge and experience in 21 CFR regulations involving GMP, Food Contact, Indirect Food Contact, Cosmetics, FDA Dietary Supplement approval, and GRAS determinations.
• Strong knowledge of 21 CFR Food Additive, Food Contact, Dietary Supplement, and Cosmetic Regulations
• Good knowledge of Generally Recognized As Safe (GRAS) requirements and FSMA, including inspection and audit processes
• Knowledge regarding GMP-Good Mfg. Practices and GDP-Good Documentation Practices.
• Ability to research, learn and properly apply information, such as standards/regulations, without direct supervision.
• Experience working in cross-functional teams.
• Experience working with leadership and team members to ensure a safety, quality and environmentally conscience culture.
• Experience in polymer chemistry is preferred.

WACKER, as an innovative chemical company, makes a vital contribution toward improving the quality of life around the world by developing intelligent solutions for sustainable growth. Our culture focuses on building and retaining diverse and inclusive teams. WACKER…