
Regulatory Affairs Engineer
hace 4 días
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 DescriptionResponsibilities:
- 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.
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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