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 skills, both written and verbal, with internal and external customers
Demonstrate strong problem solving and decision making skills
Demonstrate strong organizational skills
Knowledge of ISO quality management standards and other standards related to business sectors that support customers’ needs/products; electronic device contract manufacturing preferred
4 year College Degree or equivalent combination of education and experience as approved by executive management
5+ years of regulatory experience with moderate to complex key customers
Demonstrate the ability to interpret and communicate moderately complicated quality system regulations
Work with larger customers and more complex regulatory requirements and audits
Recommend new or revised metrics to better qualify/quantify performance
May lead continuous improvement efforts in functional or cross-functional teams
May give direction and leadership to lower level employees
Provide regulatory product support including review of change plans, CAPAs and documentation for changes requiring regulatory body approval, and post-market requirements.
Lead CAPAs and support the CAPA management process through activities such as verification of effectiveness.
Maintain internal audit requirements checklists, ensuring that applicable standards are utilized and updated as revisions are introduced.
Conduct internal audits and support external audits and inspections.
Work with cross functional teams to implement quality management system improvements
Act as a regulatory representative on product development teams and communicate regulatory requirements and impact of regulations to the development team.
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📌 Regulatory Affairs Specialist II (Tlajomulco de Zúñiga)
🏢 Benchmark Electronics
📍 Tlajomulco de Zúñiga
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