Regulatory Compliance Expert
hace 2 semanas
Job Description
Regulatory Compliance Expert needed at Grupo Preseleccion Ely S.A. to work with quality management, manufacturing, engineering, and other functional groups on regulatory and quality system compliance issues.
The ideal candidate will have a Bachelor's degree in Engineering and minimum 5 years of prior experience in medical devices industries. Minimum 2 years in Quality operations experience is desirable.
Key Responsibilities:
- Interprets, executes, and recommends modifications to operating policies/procedures where appropriate.
- Modifies, updates, and executes established programs to achieve and maintain a state of compliance.
- Provides support to the internal and external audit program.
Requirements:
- Bachelor's degree in Engineering.
- Minimum 5 years of prior experience in medical devices industries.
- Minimum 2 years in Quality operations experience is desirable.
- Advanced English skills.
- Strong knowledge of FDA and ISO regulations preferred.
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