Senior Clinical Affairs Specialist

Our Mission

Blackrock Neurotech is 100% focused on improving human lives through neuroscience research and technology. The passion and dedication behind this mission has nurtured a dynamic, enjoyable and fulfilling corporate environment in which learning, and growth are commonplace. We operate in an innovative field that requires our staff to meet the highest standards. Every step of the way, we encourage one another by providing continuous motivation and promoting a healthy work environment.

Disclosure

In order to provide a safe and productive work environment, all offers of employment at Blackrock Neurotech are contingent upon a thorough background check. A criminal history will not automatically disqualify a candidate from an offer of employment.

Senior Clinical Affairs Specialist.

Collaborate on all phases of regulatory submissions, including clinical documentation preparation and review, regulatory document review and the formulation of responses to regulatory agencies. Prepare and maintain Clinical Evaluation Reports, literature sections of Periodic Safety Update Reports and other clinical documentation for Technical Documentation File to support CE mark and other Regulatory documents. Collaborate on clinical study reports, clinical evidence gap assessments, marketing brochures, post-market surveillance reports, risk management documents and other documents. Administration of the applicable databases for the activities related to the evaluation of clinical data, Clinical Evaluation reports and Post Market surveillance reporting. Support product safety evaluation and reporting (e.g., MDR/Vigilance). Maintain regulatory files and track databases. Assist with creation and implementation of Clinical training including cross-functional learning of regulation expectations. Develop and maintain in-depth knowledge of clinical research best practices, including the planning, execution, and documentation of clinical trials, related Standard Operating Procedures (SOPs), International Standards Organization (ISO) guidelines and regulatory agencies’ guidelines on clinical research conduct. Support clinical trial management including the planning and preparation of submissions for clinical studies.

Requires Master’s degree in Regulatory Affairs and Quality Assurance, Project Management or related field and background in clinical/medical/scientific/regulatory writing; understanding of new product development teams and product lifecycle management; familiarity with implementing regulatory requirements for clinical investigations; familiarity with regulatory agency audits including FDA (Food and Drug Administration); background in direct interaction with regulatory agencies such as the IRB and FDA. Worksite Location: 630 S. Komas Drive, Suite 200, Salt Lake City, UT 84108 and Home Office (a few times per week). Resume to: Jessica Newman, Blackrock Neurotech, 630 S. Komas Drive, Suite 200, Salt Lake City, UT 84108.‬

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