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Regulatory Compliance Engineer

 

We are looking for a Regulatory Compliance Engineer who will be responsible for activities such as regulatory compliance testing which lead to and maintain domestic and international regulatory compliance for medical devices. Also responsible for assessment of device changes for regulatory implications and regulatory submissions (FDA & CE).

Annual Salary Range $80,000-100,000

The applicant must be willing to relocate to Salt Lake City, UT if not already local.

Requirements:

    —B.S. (or higher) in Electrical Engineering required
    —5-10 years minimum of progressively more responsible experience related to product development/product evaluation as it relates to process/quality/regulatory compliance
    —Five or more years demonstrated experience and expertise in achieving worldwide regulatory requirements relating to medical electrical equipment
    —Working knowledge of regulatory compliance processes involving regulatory bodies/standards such as CSA, TÜV SÜD, Health Canada, FDA, and the European Medical Device Directive
    —Reasoning Ability: Ability to define problems, interpret data, establish facts, and draw valid conclusions. Apply principles of logical or scientific thinking to a wide range of conceptual and practical problems
    —Working knowledge of standards for medical electrical equipment development such as biocompatibility, sterilization, risk management, and quality management systems including IEC 60601, ISO 10993, ISO 11135, ISO 14971, and ISO 13485
    —Technical skills: Ability to propose, coordinate, and direct tests to verify product compliance, performance, quality, and robustness. Remain current on relevant standards to support product compliance testing for both new and existing products. Strong working knowledge of safety testing equipment and techniques for the purpose of safety and environmental compliance testing
    —Strong interpersonal skills: Function as a “team player”, and work constructively and cooperatively with all departments in the interests of the business. Effectively communicate with all organizational elements and motivate people in a positive, constructive manner
    —Good organization skills: must be able to manage multiple tasks and prioritize workflow while working independently
    —Working knowledge of Microsoft Suite (Word, Excel and PowerPoint) required. Strong Excel skills required including VLOOKUP, Pivot Tables, and statistical analysis

Job Duties:

    1. Generate and review regulatory compliance test plans & results to support regulatory submissions. Function as a mentor for research and development engineers regarding techniques to achieve safety, quality and product robustness
    2. Coordinate regulatory testing with external laboratories
    3. Analyze component and field product failures; recommend corrective actions to improve failure rates
    4. Remain current and knowledgeable of all compliance standards applicable to domestic/international agencies
    5. Review software and hardware design requirements and offer improvement recommendations as related to regulatory compliance
    6. Serve as a resource to the engineering staff during product development and provide technical direction with respect to applicable standards
    7. Propose, design, and conduct tests to validate and verify product design features
    8. Perform statistical analysis of test results
    9. Generate design files for products
    10. Coordinate with other engineers and other functional areas; i.e. manufacturing to accomplish design integration, prototypes, etc.
    11. Participate with innovation team and client groups/teams formed to examine and evaluate technologies, procedures, and processes and make recommendations
    12. Perform other assignments as required by the Management

To apply, send your resume and cover letter to jobs@blackrockmicro.com.

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