Regulatory Affairs Specialist II — Quality & Compliance

Benchmark; Región Centro; Presencial; MXN 480.000 - 720.000; Jornada completa

Descripción de la vacante

Benchmark Mexico is seeking a Regulatory Affairs Specialist to perform reviews and audits of certification documentation, ensuring compliance with quality management standards and governmental requirements for contract manufacturing of products. You will support manufacturing, operations and development teams in regulatory matters.

You will participate in customer audits, monitor regulatory changes, and contribute to continuous improvement.

Formación

• Requires deep knowledge of regulatory requirements and quality standards for contract manufacturing.
• Experience in customer audits, change control, CAPAs, and documentation reviews.
• Ability to interpret ISO standards and regulatory guidance.
• Strong communication and teamwork across manufacturing, operations and development.

Responsabilidades

• Participates in regulatory department meetings and goal achievement.
• Liaises with customers on audits and specification questions.
• Supports change notifications, status clarifications, and regulatory communications.
• Monitors regulatory and quality indicators related to conformance.

Conocimientos

Regulatory compliance

Quality systems

Audits

Documentation control

Cross-functional collaboration

Communication skills

Educación

Bachelor's degree in a relevant field

Descripción del empleo

Benchmark Mexico is seeking a Regulatory Affairs Specialist to perform reviews and audits of certification documentation, ensuring compliance with quality management standards and governmental requirements for contract manufacturing of products. You will support manufacturing, operations and development teams in regulatory matters.

You will participate in customer audits, monitor regulatory changes, and contribute to continuous improvement.