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SalaryJob Title: Regulatory Affairs & Document Control Coordinator
Reports to: Director of Regulatory Affairs
Number of Direct Reports: 0
Key Internal Partners: Quality, Purchasing, R&D
Key External Partners: FCID, Kosher, Organic
Job Summary:
Under direct and general supervision, Regulatory Affairs & Document Control Coordinator/Specialist will maintain the organization and record keeping of company-wide quality, regulatory and third-party certification standards (e.g. Organic, Non-GMO Project, etc.) to ensure that all quality related issues are addressed in compliance with written procedures and/or applicable regulatory requirements. The Regulatory Affairs & Document Control Coordinator/Specialist will also develop and coordinate compliance-focused document management maintenance systems for the company’s FDA registration, and other regulatory compliance needs that may arise. Working closely with the cross-departmental Quality team, and liaising routinely with colleagues from the quality team, purchasing and R&D; will support the roll-out and maintenance of quality document management systems.
ESSENTIAL DUTIES AND RESPONSIBILITIES To perform this job successfully, you must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The following duties and responsibilities are those considered to be essential, but do not represent all job functions that may be required to be performed by this position. Other comparable duties and responsibilities may be assigned as needed.
- Support document management for all regulatory and company-wide third-party certification (e.g. Organic, Non-GMO Project, kosher, etc.) to ensure that all regulatory related issues are addressed in compliance with written procedures and/or applicable regulatory requirements.
- Keeps packaging and ingredients current and updated in all third-party certifications.
- Coordinated supportive documents for product claims and regulatory compliance.
- Review and maintain raw material documentation.
- Ensures compliance to customer Regulatory documentation and reporting requirements.
- Lead regulatory assessment on raw ingredients and food contact material; make clear recommendations on them.
- Monitor and inform on federal and state food contact regulations.
- Provide support and follow up in solving any issues as reported during organic audits.
Other duties as assigned within job scope.
INTERACTION
This position will interact closely with Quality, purchasing and R&D.
EDUCATION/YEARS EXPERIENCE
- Required: Bachelor’s degree in Food Science, Regulatory Affairs, Nutrition, or similar field, or
demonstrated equivalent experience.
- Required: 3+ years’ experience in a fast-paced, collaborative office environment.
- Required: 3+ years’ experience in a quality assurance role in food/ personal care manufacturing environment.
- Required: Experience working with comprehensive document management system.
- Any combination of educational and work experience that would be equivalent to the stated minimum requirements would qualify for consideration of this position.
KNOWLEDGE, SKILLS AND ABILITIES
- Extremely organized with outstanding attention to detail;
- Ability to communicate and collaborate constructively with a wide range of diverse colleagues and stakeholders;
- Ability to reason and analyze, to multi-task in an efficient, thorough, and prioritized manner, to work quickly, accurately and independently, and to anticipate needs and solve problems;
- Ability to take direct feedback and instructions, as well as work independently and as part of a team.
- Fluent in English with ability to correspond with a high degree of professionalism in verbal and written communication;
- Good working knowledge and advanced skills in Access, Word, Excel, Outlook, Powerpoint, SQL, and/ or relational databases, and Internet search.
- Preferred: Familiarity with FDA regulations, HACCP, SQF, standards and systems. Computer, label printing system, lab equipment, and standard office equipment.
TOOLS AND EQUIPMENT USED
- Perform work in a climate controlled office setting;
- Sit, stand, walk, reach above and below shoulder heights, climb stairs, bend and stoop, crawl, kneel and use hands, arms and legs for dexterity and balance requiring use of both arms and legs frequently.
- Experience frequent interruptions and work under pressure of time with multiple priorities.
- Occasionally lift, carry and balance objects weighing up to 35 pounds.
- Pull and push such objects as file drawers, loaded carts, pallet jack, computers and similar office equipment and supplies.
- Prioritize and multi-task work and projects requiring good memory, concentration and analytical thinking.
- Occasionally perform the safe operation of a vehicle, office equipment and machines, and recognize and abate safety hazards within the workplace.
- Frequently work alone but is occasionally required to interact or perform and communicate with others.
- Be able to hear, see including distinction of colors, read, and communicate verbally and in writing frequently with a wide range of people from diverse socio-economic backgrounds and origins.
TOTAL REWARDS
- $75,000-$85,000 Annually
- 10% bonus potential
- 20 days PTO
- 4% match on 410k
- Health care by Cigna
- Free Vision & Dental
Pay: $75,000.00 - $85,000.00 per year
Schedule:
- 8 hour shift
- Monday to Friday
Work Location: Hybrid remote in Floor 12 New York, NY 10010
