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Myriad Genetics · 2 days ago

Regulatory Affairs Associate II

SLC Metro Area

Full-time

Onsite

Entry Level

2+ years exp

Myriad Genetics is a company focused on genetic testing and precision medicine, and they are seeking a Regulatory Affairs Associate II. The role involves supporting the development and management of regulatory programs, ensuring compliance with standards, and coordinating document management and submissions with various internal teams and external agencies.

BiotechnologyPharmaceuticalPrecision Medicine

Hiring Manager

Madeline Huber

Responsibilities

Assist in the development and implementation of proactive programs to support the annual regulatory objectives and adherence to regulatory requirements and ethical behavior

Gather regulatory information and provide suggestions for improvement to department management as needed

Address common and easy problems with well understood solutions and seeking guidance from others as needed to overcome obstacles

Continually improve knowledge of current and pending revisions to regulatory guidelines and safety requirements

Establish and maintain the reports calendar for the domestic and global regulatory agencies, scheduling other required submissions as needed

Track all pending submissions, loading into the internal database system for electronic approvals, and long-term storage

Help design and manage templates to support standardization of submissions, reviewing submissions to ensure they follow the appropriate template and rewriting as needed

Qualification

Regulatory affairs experienceRegulationsResearch skillsAnalytical skillsMS Office proficiencyProblem-solving skillsTeamwork

Required

High school diploma or GED equivalent required, bachelor's degree in engineering, life science, or other technical discipline preferred

2+ years regulatory affairs (preferably medical device) required

Working knowledge of the clinical laboratory and healthcare delivery system as it relates to government agencies and the enforcement of associated federal and state regulations

Strong research, analytical, and problem-solving skills

Ability to set priorities, adapt to changing business needs, and manage multiple assignments within established time frames

Ability to work independently and on a team while filling various roles such as team member, etc

Ability to efficiently use computer programs necessary to complete work requirements (MS Word, Excel, PowerPoint, etc.)