X

Regulatory Specialist

 
Full-time
Based in Salt Lake City, Utah

Blackrock aims to provide Best of Class approved neurosciences tools to the research community to push the boundaries of human applications. We are a high-tech company that continuously innovates to empower researchers to better understand the brain.

We also aim to be the provider of implantable neural interfaces to restore function to people with neurological disorders. Blackrock already delivers some of the most critical components of leading BCI set-ups. We spend every day building technology that will benefit patients suffering from paralysis disorders, neurological diseases (ALS, Alzheimer’s, Parkinson’s), and neural dysfunctions (epilepsy, brain trauma).

Join us in the challenge and contribute the following:

What You Will Love Doing

    —Prepares regulatory submissions to the FDA, the Notified Body and other Ministries of Health
    —Assist with determining global regulatory pathways for various projects including product classification and type of regulatory submission
    —Represent RA on project teams by providing regulatory guidance throughout the product development cycle, coordinate team inputs for regulatory submissions, and review and approve applicable design control documentation
    —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
    —Coordinate regulatory testing with external laboratories
    —Remain current and knowledgeable of all compliance standards applicable to domestic/international agencies
    —Identifies guidance documents, international standards, Consensus Standards and assists teams with their interpretation
    —Responsible for assessment of device changes for regulatory implications and regulatory submissions (FDA & CE)
    —Mentor and manage Jr. Regulatory Affairs Specialist

Minimum Degree and Required Experience

    —B.S. (or higher) in Engineering, Science or equivalent education in quality related courses
    —5 or more years of progressively more responsible experience related to regulatory submissions to FDA, Health Canada, EU, and/or Australia
    —Working knowledge of standards for medical device development such as biocompatibility, sterilization, risk management, and quality management systems including IEC 60601, ISO 10993, ISO 11135, ISO 14971, and ISO 13485
    —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
    —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

What We Will Give You

    —Access to a diverse, multicultural and caring family-like team
    —The challenge of fitting various employee and company organized events (hiking, biking, football (soccer), volleyball, gaming…) into your working day
    —A free bike/ski helmet
    —Fantastic facilities with showers, bike parking and a direct view of trails up the Wasatch Front
    —Medical, vision and dental insurance
    —Life and AD&D insurance
    —Short and long-term disability insurance
    —Flexible vacation/sick leave
    —Paid maternity, paternity and adoption leave
    —401(k) with generous matching and immediate vesting
    —An opportunity for personal development and a career that will impact other people’s lives in a fundamental way

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

Blackrock Microsystems is an equal opportunity employer. All qualified applicants will received consideration for employment without regard to color, disability status, national origin, race, religion, sex, or age. However, applicants must be currently authorized to work in the United States on a full-time basis.

Share this: