Summary:

Regulatory Affairs Specialist performs reviews and audits of certification related documentation, ensuring compliance to all quality management standards, governmental rules, regulations and requirements for the contract manufacturing of products. Fosters divisional teamwork within a continuous improvement environment. Provides regulatory and quality systems support for manufacturing, operations and product development.

Responsibilities:

Participates and contributes to regulatory departmental management meetings and goal accomplishment
Serves as customer team liaison for customer audits/questions related to specification requirements
Works directly with customers, as required, in support of the customer teams, interfacing on change notification activities, clarification of status and other such communication
Monitors and report on key quality and performance indicators as related to regulatory system conformance
Keeps updated on latest and future regulatory requirements and quality management standards, incorporating changes and additions into review and audit practices




Actively participates in continuous improvement initiatives
Reviews applicable procedures and work instructions/forms supporting quality system regulation processes for compliance to requirements
Participates with customer teams, supporting NPI and ongoing production needs related to regulatory requirements

Other information:

Ability to interpret, understand, and apply regulatory requirements and quality management standards as applicable to assigned customers, projects and/or products
Capable of performing timely and accurate review of MRR and MRR waiver submittal
Capable of performing timely and accurate review of validations such as IQ, OQ and PQ documentation
Demonstrate effective customer interface skills
Demonstrate confidentiality
Ability to work with supervision and guidance
Demonstrate strong and effective interpersonal skills
Demonstrate strong presentation and communication s

📌 Regulatory Affairs Specialist II (Tlajomulco de Zúñiga)
🏢 Benchmark
📍 Tlajomulco de Zúñiga