Regulatory Compliance Manager

Posted: 06/07/2022

What To Expect:
The Regulatory Compliance Manager will develop and align the organization to ensure Good Manufacturing Practice (GMP) and regulatory compliance in the labeling, manufacturing, packaging, and distribution of Nutraceuticals by Ortho Molecular Products.  In addition, you will oversee and manage label compliance, international product registration and documentation according to applicable regulations as it relates to National and International regions of business.

  • Monitor regulatory trends and industry standards including international focus.
  • Maintain a high awareness of emerging regulatory issues and industry standards.
  • Manage product registrations with Health Canada and other international markets.
  • Assist in hosting all regulatory agencies and customers performing audits.
  • Evaluate compliance issues and recommend remedial actions required.
  • Review and approve investigation and remedial action reports and make regulatory decisions.
  • Assure product label and literature compliance with FDA and FTC regulatory obligations.
  • Oversee and manage product label development, while maintaining a state of control.
What You Will Contribute:
  • BS/BA in a related Science field and/or Regulatory Sciences
  • 3-5 years of regulatory compliance experience and/or training education equivalent combination of experience. TGA, EU European Union, Health Canada preferred certification experience.
  • Minimum 3 years’ experience in an FDA regulated manufacturing facility.
  • ASQ certification desired. CMQ/OE (Manager of Quality/Operational Excellence), CQA (Quality Auditor), Six Sigma Green or Black Belt training desired.
  • Proficient in the Microsoft Office Suite (includes Word, Excel, Access and PowerPoint); experience in SharePoint and ERP systems desired.
What You Will Receive:
  • Competitive Compensation with Bonus Program
  • Medical, Dental, Vision, Company Paid Life Insurance, and 401K with Employer Match
  • Voluntary Benefits: Short Term Disability, Life, Critical Illness, Accident, & Hospital Indemnity
  • Paid Time Off and Holidays
  • Job Specific Training (No Experience Required) & Tuition Reimbursement program
  • Wellness & EAP program, Gym Reimbursements, and Healthy, Company Paid Meals
  • Free Monthly Products, Employee Discounts, and Employee Referral Incentives
Why Work at Ortho Molecular Products: 
Simply put, our healthcare system is broken. It is expensive, complicated, and dysfunctional. At Ortho Molecular Products, our vision is to transform the practice of medicine. Every day, across America and the world, we help health care providers implement better solutions for health challenges that include lifestyle medicine and nutritional therapies proven to improve patient outcomes. We do this by manufacturing science-based products and developing innovative clinical programs for doctors that help their patients get better faster.
 
We are looking for people who align with our mission and want to invest their lifework and passion into transforming the practice of medicine. Our team is purpose-driven, values-based, and service-focused. We are looking for likeminded people who want to join the movement that is changing the way healthcare is being delivered.
 
Ortho Molecular Products is an Equal Opportunity Employer and encourages women minorities, protected veterans and individuals with disabilities are encouraged to apply.