Job Summary: 

The position is responsible for development and implementation of Global Regulatory Affairs and Product Compliance to provide regulatory oversight of compliance program for dietary supplements (21 CFR Part 111), nutritional supplements, foods (21 CFR Part 117, 21 CFR Part 110) and personal care & cosmetics (Federal Food, Drug, and Cosmetic Act and Fair Packaging and Labeling Act). The position interfaces closely with Legal, Product Development and Quality Departments to ensure Federal, State, Local and International regulations and compliance efforts in maintaining food safety and cosmetics, label compliance, regulatory inspections, recall, complaints, product registrations and certifications. 

Job Expectations:

  • Develop and manage compliance program for Food, Dietary and Nutritional Supplements under FDA Title 21 CFR Part 110, 111 and 117, etc.), and Personal Care and Cosmetics (Federal Food, Drug, and Cosmetic Act and Fair Packaging and Labeling Act)

  • Maintain and disseminate current knowledge of FDA and international regulation, guidance, standards and industry best practice

  • Ensure the company preparedness for regulatory inspection and lead preparation and execution of regulatory response

  • Develop and implement Food Safety Modernization Act (FSMA) compliance program

  • Review and approve new and existing label, formula, raw material and finished product specifications to assure compliance with regulatory requirements

  • Prepare and process documentation required for product registrations and certifications in applicable international markets and provide technical registration dossiers that fulfill specific country regulations 

  • Assess House Brands claims, labeling, formulas and ingredients (labels, website, ecommerce, etc.) to ensure compliance with domestic and international regulations. 

  • Monitor and review product formula changes and label revisions to ensure compliance with regulatory requirements

  • Approve the release of reviewed labels as directed

  • Manage third-party accredited certifications for Kosher, Halal, non-GMO, Organic, Gluten-free, etc.

  • Work closely with Quality Assurance Auditor for the internal audit program and corrective action/preventive action (CAPA) implementation 

  • Manage and investigate customer complaints, root cause analysis for non-conforming products, and corrective action and preventive action 

  • Perform periodic mock recalls, and participate in FDA product recall

  • Identify quality and regulatory challenges based on risk and global basis to ensure applicable requirements are met for House Brand products that are being sold world-wide

  • Conduct supplier and product risk assessments and identify vulnerabilities

  • Define and monitor metrics to track compliance and process effectiveness 

  • Develop, design, write standard operating procedures (SOPs) ensuring compliance with the company's policies and FDA regulations

  • Assist Senior Quality Assurance Manager in ensuring compliance with Standard Operating Procedures (SOPs), GMP, regulatory requirements and Job Aids related to daily tasks

  • Perform other duties as assigned

The duties and responsibilities described above may provide only a partial description of this position. This is not an exhaustive list of all aspects of the job.  Other duties and responsibilities not outlined in this document may be added as necessary or desirable, with or without notice.

 

Knowledge, Skills and Abilities:

  • Knowledge of FDA/ Local and Global regulations

  • Strong analytical, data management knowledge 

  • Ability to communicate written and verbally in a professional manner with people at all levels of the organization and external contacts

  • Able to work in a fast pace environment

  • Detail oriented, strong analytical skills, team-player

                                     

Equipment Knowledge:

  • Experience with Microsoft Office Suite (Word, Excel, PowerPoint)

  • Experience with Google Business Suite (Gmail, Drive, Docs, Sheets, Forms) preferred

 

Experience Requirements:

Generally, requires three (3) to five (5) years of relevant industry experience in R&D, manufacturing, quality Assurance and/or regulatory affairs. PCQI certified a plus.

 

Education Requirements:

Bachelor’s Degree in Food Science, Chemistry or related field preferred, or a combination of education and equivalent work experience.

 

 

#LI-ZL1

#MO

About iHerb
iHerb is a leading global e-commerce retailer  with an emphasis on providing an exceptional selection of nutritional and wellness products for the past 25 years. With over 30,000 products shipped to over 180 countries, we provide the best overall value for natural products through an innovative and efficient supply chain process. 

Our teams have a strong sense of commitment and pride in their work, which has allowed us to grow, even during the recent pandemic. At iHerb, our purpose is to empower people to enhance their health, happiness, and well-being — that starts with valuing our team members by providing a positive work environment with competitive benefits. Our five  shared values unite our team members across the globe and provide a stable foundation. These values speak to who we are, the culture we’re building, and how every single team member contributes to our larger company vision. 

iHerb's Shared Values
Focus on the Customer · Empower Our People · Be Entrepreneurial & Pivot Quickly · Embrace Diversity & Inclusion · Strive for Simplicity

iHerb Benefits
At iHerb, we are dedicated to offering programs designed to help our employees and their families stay healthy, live well and plan for the financial future. Built on a strong foundation, our programs provide options and upgrades with flexibility, protection, and security in mind. Below is a snapshot of the benefits we offer our team members.  For a more comprehensive listing, visit www.iHerbBenefits.com. 

  • Medical Care: Starting in 2021, iHerb covers 100% of the associated cost for medical benefits
  • Dental and Vision benefits
  • Safe Harbor 401(k) + company match (100% of the first 6% of the employee’s contribution)
  • Company-paid Term Life Insurance
  • Short and Long Term Disability
  • Flexible Spending Account (for qualifying expenses)
  • Pet Insurance
  • Voluntary Supplemental Benefits
  • Education Reimbursement Programs
  • Professional Development and Job Training
  • Wellness Programs with opportunity to earn up to $300 per year


We strive for innovation, targeted at delivering a customer-centric experience while transforming the online shopping experience. We change direction and define ourselves in the idea that individually we are incredible but united our growth is infinite and paramount to our success. iHerb strives to be the global industry leader!

iHerb is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status. iHerb provides equal employment opportunities to all applicants for employment and prohibits discrimination and harassment.

Apply for this Job

* Required

  
  


U.S. Equal Opportunity Employment Information (Completion is voluntary)

Individuals seeking employment at iHerb are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.


Form CC-305

OMB Control Number 1250-0005

Expires 05/31/2023

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Autism
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
  • Blind or low vision
  • Cancer
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or hard of hearing
  • Depression or anxiety
  • Diabetes
  • Epilepsy
  • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
  • Intellectual disability
  • Missing limbs or partially missing limbs
  • Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)
  • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

1Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.