Regulatory Affairs Engineer

hace 4 días


San Juan, San Juan, Puerto Rico Mentor Technical Group A tiempo completo

About Our Team

We are a world leader in life science engineering and technical solutions, providing comprehensive portfolios of technical support and solutions for the FDA-regulated industry.

Our team is dedicated to ensuring compliance with FDA, ISO, and internal quality systems regulations.

We have offices in various locations, serving clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.

Job Description

Responsibilities:

  • Develop and implement quality management systems to ensure compliance with FDA, ISO, and internal quality systems regulations.
  • Lead and develop a team of associates to ensure effective quality management.
  • Investigate and resolve manufacturing-related issues.
  • Develop and implement corrective actions to prevent future issues.
  • Ensure compliance with regulatory requirements and industry standards.
  • Collaborate with cross-functional teams to achieve business objectives.

Education and Experience

Bachelor's degree in Engineering (Industrial or CQE preferred).

A minimum of 7 years' experience in manufacturing, quality control, quality assurance, or regulatory compliance, preferably in the medical device or pharmaceutical industry.

Advanced degree or process towards advanced degree is a plus.


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