COMPANY OVERVIEW

Icelandirect, Inc. is a leader in the fish oil and nutritional supplements industry, committed to providing high-quality products sourced from sustainable fishing practices. Our mission is to deliver premium Omega-3 oils and fish powders while adhering to the highest standards of quality and environmental responsibility.

SUMMARY

We are seeking a Documentation Manager to join our team in the US. This role is crucial in ensuring that our documentation processes align with regulatory standards and support our commitment to quality. The ideal candidate will play a key role in maintaining compliance and enhancing our operational efficiency.
The Documentation/Regulatory Manager is responsible for managing all regulatory compliance and document control functions at Icelandirect LLC. This includes ensuring that labeling, certifications, SOPs, and product records comply with FDA, NSF, and other industry standards. The role ensures accuracy, consistency, and timely management of documentation while supporting audits, inspections, and regulatory submissions.
Principal Responsibilities (others may be assigned):
· Oversee creation, approval, and maintenance of SOPs, Master Manufacturing Records, and regulatory documentation.
· Ensure product labeling meets FDA, NSF, and international regulatory requirements.
· Manage regulatory submissions and certifications, including NSF, cGMP, and customer-specific requirements.
· Coordinate document control, ensuring proper versioning, storage, and retrieval of controlled documents.
· Support FDA, NSF, and third-party audits by ensuring documentation accuracy and readiness.
· Train employees on regulatory requirements, SOP adherence, and documentation practices.
· Maintain up-to-date knowledge of regulatory changes and ensure timely updates to company policies and procedures.
· Investigate and resolve regulatory or documentation issues in collaboration with QA/QC and Operations.
· Develop and monitor KPIs related to regulatory compliance and document management.
· Provide regulatory guidance to R&D and Sales for new product development and labeling claims.
Principal Relationships:
Internal – VP of Technical Services, QA/QC Director, R&D Director, Operations, Supply Chain, Sales & Marketing
External – Regulatory agencies (FDA, NSF), auditors, certification bodies, customers
Supervision:
Direct – Documentation Specialists, Regulatory Associates
Indirect – QA Clerks, interns
Additional Requirements:
Education – Bachelor’s degree in Life Sciences, Regulatory Affairs, or related field.
Experience – Minimum 7 years of experience in regulatory affairs or documentation management within nutraceuticals, pharmaceuticals, or food manufacturing. Experience with FDA labeling regulations and regulatory submissions required.
Computer Skills – Proficiency with MS Office, ERP/MRP systems, and document control software.
Job Type: Full-time
Pay: From $90,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Application Question(s):

• How many years of experience do you have in regulatory affairs and documentation management?
• Have you worked in the nutraceutical, dietary supplement space?
• Which electronic documentation or quality systems have you used?
• Have you ever managed a documentation/regulatory team? If so, how many people?

Ability to Commute:

• Clifton, NJ 07014 (Required)

Work Location: In perso

Please refer the Job description for details