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