- Responsible for managing Wacker's corporate FDA food contact program. Refine current procedures and strategy to accommodate growing business needs. Create and revise Wacker's Food Contact Evaluation letters for customers. Determinations made by reviewing chemical formulas for raw materials and Wacker formulations. Interface with Wacker Quality Management for review and signoff on Good Manufacturing Practices and 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.
- Manage submissions to third party certification organizations such as NSF International. Familiarity with Canadian Food laws and serving as the liaison between Wacker and our Canadian Regulatory Agent.
- Responsible for ensuring Wacker regulatory compliance to FDA food and cosmetic regulations. Work with Corporate Departments to develop processes which ensure ongoing compliance to current FDA regulation requirements under all aspects of Food (including food contact) and cosmetic products produced or offered for sale in US. Maintain working relationship with Divisional Management to ensure compliance knowledge needs are met, as well as provide support and input for International regulatory requirements and external standards including USP-NF, Food Chemical Codex (FCC) where applicable. Familiarity with Canadian Food laws and serving as the liaison between Wacker and our Canadian Regulatory Agent.
- Obtain quotes for outside food contact related legal opinions and consultation. Interface with FDA on product submissions, and track progress of their reviews.
- Maintain and update Wacker's FDA Food facility registrations, as well as serve as interface for other interactions (Export certificates and filings).
- Communicate relevant updates to FDA current and proposed regulations to applicable Wacker departments and divisions.
- Have basic working knowledge of Divisional product groups and end use applications for Wacker products and provide overarching guidance and interface with Divisional and Site Quality Managers and Business Team members to ensure compliance to current and upcoming FDA regulations, International regulatory requirements and external standards including USP-NF, FCC where applicable for each site. Participate in Wacker site internal, Regulatory, and 3rd party compliance audits. Provide support during FDA site inspections.
- 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.
- Bachelor of Science Degree in Biology, Chemistry, Toxicology, or Food Science. Master's degree is preferred.
- 7+ 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.
- Compensation and Incentive plans
- Medical, Dental, and Vision Insurance effective day 1
- Paid Time Off in addition to personal days and holidays
- Paid parental leave
- Wellbeing fund
- Flexible hybrid work arrangements
- 401(k) with company match
- Education Assistance Program
- Career development and advancement opportunities
- Support for Community Involvement
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Senior Regulatory Affairs Specialist-FDA Food 1 - Ann Arbor, United States - Wacker Chemical
Description
Date:May 3, 2024
Location:
Ann Arbor
Company:
Wacker Chemical Corporation
Do you want to take responsibility and make a difference with your work? With your expertise, we can achieve great goals together. We are WACKER - Reliable. Determined. Ambitious. As one of the world's most research-intensive chemical companies, we've been making countless products that are an integral part of your everyday life possible for over 100 years. From vegan food to resource-efficient buildings to solar cells, we develop sustainable solutions that change the future.
To strengthen our team in Ann Arbor,
we are looking for you as a(n) Senior Regulatory Affairs Specialist-FDA Food 1.
Position Overview:
This position is responsible for managing all data submissions to the US FDA for Food, Food Contact and Cosmetic products, maintain global food facility registrations, provide support for FDA import classifications, as well as reviews of chemical formulations. This position will respond to product compliance requests and be required to utilize available government databases. This role will support Wacker business team members to ensure compliance to FDA, Food Chemicals Codex (FCC), Responsible Care and cosmetic standards and regulations. This position must be able to interpret and ensure compliance to all current and future FDA regulation requirements, must have working knowledge of food safety requirements under Food Safety Modernization Act (FSMA), hold certification as a (PCQI), and have certification in / or willingness to become certified as internal auditor for food and cosmetics.
Job Responsibilities
FDA Food Contact Program Management and Compliance:
Corporate FDA Food and Cosmetic Compliance Programs
Divisional FDA Food and Cosmetic Compliance Programs
Document Control:
Job Qualifications
#LI-LGI
What do we offer?WACKER is an equal opportunity employer committed to diversity, equity, inclusion, and sustainability. We are innovators, researchers, and pioneers and we believe that our individual differences are our collective strength. We foster an inclusive environment that promotes individuality, celebrates diversity, and builds cohesive teams. Together, we create exceptional value for our employees, our customers, and our communities by creating a culture of inclusion and equity that enables, empowers, and values our diverse contributions.
WACKER strives to reward its employees in a fair and equitable manner. Our Total Rewards Package considers employee wellbeing and is comprised of compensation, benefits, work-life balance, performance & recognition, and career development.
Reference Code:26905
#LI-JS1
The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job.
A minimum requirement for this US-based position is the ability to work legally in the United States on a permanent unrestricted basis. Visa sponsorship is not available for this position, including for any type of US permanent residency (e.g., for a green card).
WACKER is proud to be an Equal Opportunity/Affirmative Action Employer, making decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability, or any other protected class.
Nearest Major Market: Ann Arbor
Nearest Secondary Market: Detroit
