Regulatory Affairs Specialist III in Brașov at Benchmark Electronics

Date Posted: 9/26/2019

Job Snapshot

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    Not Specified
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Job Description

Job Title
Regulatory Affairs Specialist III

Job ID(Requisition ID):

Job Summary
Performs reviews and audits of certification related documentation, assuring compliance to all governmental rules, regulations and requirements for the contract manufacturing of products. Fosters divisional teamwork within a continuous improvement environment.

Essential Functions and Competencies

Ability to interpret, understand, and apply regulatory requirements 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 effective interpersonal skills Demonstrate strong 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 Have some knowledge of ISO type Quality Systems that support customers’ needs/products; electronic device contract manufacturing preferred Demonstrate the ability to interpret and communicate complicated quality system regulations Demonstrate the ability to exercise discretion and independent judgment without much oversight Ability to pass and obtain internal certifications for Quality Systems Auditor and Regulatory Auditor
Qualifications / Education / Experience
Serve as customer team liaison for customer audits/questions related to specification requirements Work directly with customers, as required, in support of the customer teams, interfacing on change notification activities, clarification of status and other such communication Monitor and report on key quality and performance indicators as related to regulatory system conformance Keep updated on latest and future regulatory requirements, incorporating changes and additions into review and audit practices Review applicable procedures and work instructions/forms supporting QSR, processes for compliance to requirements Participate with customer teams, supporting NPI (New Product Introduction) and ongoing production needs related to regulatory requirements Manage and lead the Division quality system to ensure it meets various certification requirements Assist in the development of software and process validation protocols Perform advanced QSR training and related GMP’s (Good Manufacturing Processes) Participate on Quality Planning Committee Coordinate internal and external regulatory audits Maintain process and system audit procedures; Analyze and incorporate performance data into applications and other regulatory requirements Perform internal system audits 3+ years of regulatory experience with moderate to complex key customers 4 year College Degree or equivalent combination of education and experience
Job Category
Job Location
Brasov, Romania

Pay Type
Travel Requirement
Job Type

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