Regulatory Compliance Specialist

1 week ago


Totowa, New Jersey, United States Englewood Lab, Inc Full time

Job Overview

Englewood Lab, Inc is a leading organization in the pharmaceutical and cosmetic industry, seeking a highly skilled Regulatory Compliance Specialist to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements, managing product registrations, and maintaining accurate records.

Salary: $60,000 - $80,000 per year

Responsibilities:

  • Compliance Management: Develop and implement compliance strategies to ensure adherence to regulatory guidelines, including FDA, EPA, OSHA, and ISO 13485:2003 standards.
  • Product Registrations: Manage product registrations, renewals, and document submissions to regulatory agencies, under the supervision of the Head of Quality/Regulatory.
  • Document Control: Maintain accurate and up-to-date documentation, including SOPs, technical documents, and quality management system (QMS) records.
  • Training and Development: Assist in the development and delivery of training programs, including annual GMP training, to ensure staff understanding of regulatory requirements.

Requirements:

  • Bachelor's degree in Life Sciences, Engineering, or related field.
  • Minimum 1+ years of experience in regulatory affairs, quality management, or a related field.
  • Familiarity with FDA requirements under 21CFR 210, 211, & 820.
  • Excellent communication and analytical skills.

Benefits:

  • Medical, Dental, and Vision Insurance.
  • Life Insurance.
  • 401k match.

Located in Englewood, CO, this role offers a competitive salary and excellent benefits package. If you are a motivated and detail-oriented individual with a passion for regulatory compliance, we encourage you to apply.



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