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Job Profile
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Benchmark Electronics, Inc.
Regulatory Affairs Specialist I
Job Location: Winona, Minnesota
Job Type: Full-Time
Department:
Administrative
Shift:
Day
Summary:
Perform review and audits of QSR/FDA related documentation, assuring compliance to all governmental rules, regulations and requirements for the contract manufacturing of electronic medical devices. Foster divisional teamwork within a continuous improvement environment.
• Participates and contributes to regulatory departmental management meetings and goal accomplishment.
• Serve as customer team liaison for customer audits/questions related to QSR and FDA requirements.
• Works in conjunction with more senior departmental personnel communicating with customers as required in support of the customer teams, interfacing on change notification activities, clarification of status and other such communication.
• Monitors and reports on key quality and performance indicators as related to regulatory system conformance.
Benchmark Electronics will not discriminate against any employee or applicant for employment because of race, color, religion, sex, national origin, disability, or veteran status. Benchmark Electronics will take affirmative action to ensure that applicants are employed and that employees are treated during employment without regard to their race, color, religion, sex, national origin, disability, or veteran status.
Skills Required:
• Will have some knowledge of ISO type Quality Systems, those supporting QSR, FDA and Medical requirements as applicable to electronic device contract manufacturing preferred.
• Will be able to interpret, understand, and apply regulatory requirements as applicable to assigned customers, projects and or products.
• Will be capable of performing timely and accurate review of MRR and MRR waiver submittals.
• Will be capable of performing timely and accurate review of validations such as IQ, OQ and PQ documentation.
• Will review applicable procedures and work instructions/forms supporting QSR, processes for compliance to requirements.
• Participate with customer teams, supporting NPI and ongoing production needs related to regulatory requirements.
• Will demonstrate effective customer interface skills.
• Will demonstrate confidentiality.
• Will work with supervision and guidance.
• Will demonstrate regular, consistent attendance.
• Will demonstrate effective interpersonal skills.
Experience Required:
1+ years experience in a manufacturing environment, working in the regulatory and/or quality auditing environment preferred.
Education Required:
• Must have a 4-year college degree.
How To Apply:
Benchmark Electronics, Inc.
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