Regulatory Affairs Specialist II — Compliance & Quality

Benchmark Electronics Inc; Región Centro; On-site; MXN 360,000 - 600,000; Full time

Job summary

Benchmark Electronics Inc. seeks a Regulatory Affairs Specialist II to perform reviews and audits of certification documentation, ensuring compliance with quality and regulatory standards in contract manufacturing.

You will support manufacturing, operations and product development, lead change notifications, and interact with customers and internal teams to maintain regulatory conformance.

Qualifications

• 4 year College Degree or equivalent required.
• 5+ years of regulatory experience with moderate to complex customers.
• Ability to interpret and communicate regulatory requirements and impact of regulations.
• Knowledge of ISO quality management standards and related requirements.

Responsibilities

• Participates in regulatory department meetings and goal accomplishment.
• Serves as customer team liaison for customer audits and questions on specification requirements.
• Interacts with customers and internal teams on change notification activities and status clarifications.
• Monitors and reports key quality and performance indicators related to regulatory conformance.
• Keeps updated on latest regulatory requirements and quality standards and incorporates changes into review and audit practices.
• Leads continuous improvement initiatives within the regulatory function.
• Reviews procedures and forms supporting quality system regulation processes for compliance.
• Supports NPI and production needs related to regulatory requirements with customer teams.

Skills

Regulatory experience

Communication skills

Presentation skills

Problem solving

Organizational skills

Interpersonal skills

ISO standards knowledge

Education

Bachelor's degree or equivalent

Job description

Benchmark Electronics Inc. seeks a Regulatory Affairs Specialist II to perform reviews and audits of certification documentation, ensuring compliance with quality and regulatory standards in contract manufacturing.

You will support manufacturing, operations and product development, lead change notifications, and interact with customers and internal teams to maintain regulatory conformance.