Regulatory & Quality Compliance Specialist II

Benchmark Electronics Inc; El Salto; Presencial; MXN 600.000 - 900.000; Jornada completa

Descripción de la vacante

Benchmark Electronics Inc is seeking a Regulatory Affairs Specialist II to review certification documents and ensure compliance with quality management standards, governmental rules, and regulatory requirements for contract manufacturing of products.

The role supports manufacturing, operations, and product development, interacts with customer teams during audits and change notices, and participates in continuous improvement initiatives to maintain compliance across projects.

Formación

• 4 year College Degree or equivalent
• 5+ years of regulatory experience with moderate to complex key customers
• Knowledge of ISO quality management standards and audits

Responsabilidades

• Participates in regulatory departmental management meetings and goal accomplishment
• Interacts with customer teams for audits and specification requirements
• Reviews regulatory documentation and supports change notification activities
• Monitors regulatory system conformance and reports on KPIs
• Maintains knowledge of current regulatory requirements and industry standards
• Leads CAPAs and supports CAPA management process when applicable
• Conducts internal audits and supports external audits and inspections
• Works with cross functional teams to implement quality system improvements
• Acts as regulatory representative on product development teams

Conocimientos

Regulatory compliance

Quality systems

Audits

Customer liaison

Documentation

Change control

Regulatory interpretation

Interpersonal skills

Problem solving

Organizational skills

Educación

Bachelor's degree

Descripción del empleo

Benchmark Electronics Inc is seeking a Regulatory Affairs Specialist II to review certification documents and ensure compliance with quality management standards, governmental rules, and regulatory requirements for contract manufacturing of products.

The role supports manufacturing, operations, and product development, interacts with customer teams during audits and change notices, and participates in continuous improvement initiatives to maintain compliance across projects.