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Senior Regulatory Affairs Specialist

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Judge Group, Inc.

2021-12-03 08:50:33

Job location Redmond, Washington, United States

Job type: fulltime

Job industry: Government & Defence

Job description

Location: Redmond, WA
Salary: Competitive
Description: Our client is currently seeking a Senior Regulatory Affairs Specialist

Description: The primary function is the evaluation of new and revised electro-medical devices and accessories to international safety standards. Responsible for the creation and maintenance of evaluation and certification reports. Responsible for the creation and revision of Technical Documentation files. This includes review of IEC test procedures and reports, compliance to safety standards and requirements, in-house as well as external testing, certifications and requirement checklists. Will need to interface with project teams and other departments.

Essential Duties & Responsibilities:

Review and evaluate test data, specifications, engineering and user documentation, physical construction, marking and labeling, hazard analysis, clinical reports, Declaration of Conformity, EMC protocol and test reports and, the technical description of essential components and materials.

Provides content for the preparation and revision of Technical Document Files and other certification reports

Helps create and maintain overall isolation diagrams.

Collaborates with engineering project teams in designing new or revised products that will be compliant.

Ability to work on several projects and partner with internal and external department teams.

Implements engineering documentation of high complexity.

Assists in the development and design of process changes under the direction of more senior engineers.

Perform other duties as assigned.

Basic Qualifications:

A Bachelor's degree in electrical engineering or related discipline.

Minimum 3 years' experience with safety standards, product compliance and certifications.

Preferred Qualifications:

Familiarity with IEC standards for medical devices, such as IEC 60601-1 and IEC 60601-2-4, ISO 17025, ISO 14971, CE-Mark, Technical Documentation Files and safety agencies like UL, CSA, TUV and BSI

Familiarity with high-voltage circuits and isolation.

Familiarity with test and measurement equipment operation such as dielectric, leakage and ground impedance testers and DVMs.

Good computer skills with mid-range knowledge of Word, Excel and PowerPoint

Good written and verbal communication skills.

Understand basic analog circuits and components.

Familiarity with safety standards evaluation, test and certification processes.

Contact:

This job and many more are available through The Judge Group. Find us on the web at - provided by Dice

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