Regulatory Affairs Specialist II - *****Posted 2 days agoDescriptionSummary: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 accomplishmentServes as customer team liaison for customer audits/questions related to specification requirementsWorks directly with customers, as required, in support of the customer teams, interfacing on change notification activities, clarification of status and other such communicationMonitors and report on key quality and performance indicators as related to regulatory system conformanceKeeps updated on latest and future regulatory requirements and quality management standards, incorporating changes and additions into review and audit practicesActively participates in continuous improvement initiativesReviews applicable procedures and work instructions/forms supporting quality system regulation processes for compliance to requirementsParticipates with customer teams, supporting NPI and ongoing production needs related to regulatory requirementsOther information:Ability to interpret, understand, and apply regulatory requirements and quality management standards as applicable to assigned customers, projects and/or productsCapable of performing timely and accurate review of MRR and MRR waiver submittalCapable of performing timely and accurate review of validations such as IQ,



OQ and PQ documentationDemonstrate effective customer interface skillsDemonstrate confidentialityAbility to work with supervision and guidanceDemonstrate strong and effective interpersonal skillsDemonstrate strong presentation and communication skills, both written and verbal, with internal and external customersDemonstrate strong problem solving and decision making skillsDemonstrate strong organizational skillsKnowledge of ISO quality management standards and other standards related to business sectors that support customers' needs/products; electronic device contract manufacturing preferred4 year College Degree or equivalent combination of education and experience as approved by executive management5+ years of regulatory experience with moderate to complex key customersDemonstrate the ability to interpret and communicate moderately complicated quality system regulationsWork with larger customers and more complex regulatory requirements and auditsRecommend new or revised metrics to better qualify/quantify performanceMay lead continuous improvement efforts in functional or cross-functional teamsMay give direction and leadership to lower level employeesProvide 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 improvementsAct as a regulatory representative on product development teams and communicate regulatory requirements and impact of regulations to the development team.
#J-*****-Ljbffr

📌 Regulatory Affairs Specialist Ii - 12277 (Jalisco)
🏢 Benchmark Electronics
📍 Jalisco