Myriad Genetics

We're a leading genetic testing and precision medicine company dedicated to advancing health and well-being for all.

Regulatory Affairs Associate II

ComplianceComplianceFull TimeRemoteTeam 1,001-5,000Since 1991H1B SponsorCompany SiteLinkedIn

Location

Utah

Posted

86 days ago

Salary

$70K - $82.1K / year

High School2 yrs expEnglish

Job Description

• 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.

Job Requirements

  • High school diploma or GED equivalent required, bachelor’s degree in engineering, life science, or other technical discipline preferred.
  • 2+ years of related professional experience and including direct experience in regulatory affairs (preferably medical device).
  • 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.)

Benefits

  • EEO
  • Health insurance
  • Flexible work arrangements

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