| Company: | Myriad Genetics |
| Job Location: |
Salt Lake City - Salt Lake County |
| Employment Type: | Full Time |
| Benefits: | Please see benefits link at www.myriad.com/careers |
Description: |
| This position will be responsible for administrating the regulatory compliance program and will be responsible for coordinating/managing compliance activities within the clinical laboratory. The position works with the Quality and Regulatory Compliance team to evaluate and oversee the organization's policies and practices to ensure compliance with industry standards and applicable regulations. Knowledge of current regulatory requirements regarding HIPAA regulations, clinical laboratory standards (CLIA/CAP), billing compliance (CMS) along with state regulations (e.g. NY, CA) and FDA medical device (diagnostics) regulations required. The ability to interface with regulatory authorities and accreditation agencies to ensure business practices are in compliance with current industry requirements, and lead negotiations for licenses or other regulatory permissions is desirable. |
Duties: |
Evaluates, oversees and administrates compliance activities within the laboratory to ensure regulatory compliance through procedure reviews, audits and incident reviewsDevelops and administers an ongoing compliance program for all laboratory personnel in conjunction with the senior staff/department management and other departmental liaisons.
Creates, compiles and distributes reports regarding compliance, quality measures and business metrics.
Leads/assists in training and developing staff to ensure that a qualified staff exists to meet company objectives in the area of process improvement and quality.
Participates in the development and compilation of regulatory document submissions.
Leads/assists in the administration of proficiency tests for the clinical programs.
As needed, participates in quality improvement project teams to ensure that organization’s objectives are met.
Additional duties as assigned.
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Qualifications: |
BS/MS degree in life sciences. Minimum of 5+ years experience in quality assurance or regulatory environment with specific experience in clinical laboratory compliance.
Ability to work independently and as part of a team.
Working knowledge of clinical laboratory regulations and compliance standards required, including CAP, CLIA, FDA and state regulatory requirements.
Working knowledge of computers including MS Office suite and queries preferred.
Strong leadership skills. Ability to drive change and implement new processes rapidly.
Excellent teamwork, communication, influence and persuasion skills.
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