Regulatory Compliance and Quality Assurance Manager

7 days ago


Rockville, Maryland, United States US Fertility, LLC Full time
Job Overview

US Fertility, LLC is seeking a highly skilled Regulatory Compliance and Quality Assurance Manager to join our team. This role will be responsible for ensuring the company's quality systems and regulatory compliance with all relevant agencies.

The successful candidate will have a strong background in quality assurance and regulatory compliance, with experience in implementing and maintaining quality systems, document control, and audit processes.

Key Responsibilities:
  • Implement, monitor, and maintain the company's Quality System to ensure compliance with regulatory requirements
  • Develop and implement a document control system to manage and track documents
  • Ensure compliance with federal and state regulations applicable to the products produced/processed
  • Facilitate quarterly meetings with medical directors to provide regulatory and quality updates
  • Assure appropriate licensure is held and maintained by the company
Requirements:
  • Bachelor's degree or equivalent combination of training and experience
  • Must have a high level of interpersonal skills to handle sensitive and confidential situations
  • Clear and effective communication skills
  • Proficiency in computer software applications, including word processing, spreadsheets, and presentation software
  • Self-starter that adapts well to change in a fast-paced environment
Estimated Salary:

$110,000 - $130,000 annually



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