13 days old

Assoc Scientist I

Myriad Genetics, Inc
Salt Lake City, UT 84101
  • Job Code
Location: Salt Lake City, UT, United States
Job Identification: 446
Job Schedule: Full time

The Quality Assurance & Regulatory Affairs team of Myriad Genetic Laboratories is seeking a full-time Scientist or Associate Scientist to work on molecular diagnostic tests regulated by the FDA, CLIA, CAP, NYSDOH, and international regulatory agencies. Current projects include PMA and IDE submissions for companion diagnostic (CDx) tests.

The responsibilities of the Associate Scientist or Scientist will include:
1. Contributing to FDA PMA, 510(k), and IDE submissions.
2. Support other regulatory submissions, e.g. Japan PMDA, CE marking, NYSDOH, CLIA/CAP and MolDX.
3. Ensure Quality System Regulations (QSR), ISO (e.g. 13485), CLIA/CAP, NYSDOH, and relevant international regulatory compliance for molecular diagnostic testing.
4. Defining, writing up and planning/leading/performing feasibility, development, verification and validation studies.
5. Support Regulatory Affairs and Quality Assurance teams. Participate in audits as needed.
6. Support development and production teams/laboratories.
7. Participate in device and process improvements as needed.
8. All aspects of the work will be performed under design control.
9. Cross-functional collaboration and coordination with program/project managers and relevant teams and stakeholders to meet defined deliverables and timelines.
10. Other related duties as needed.

Ph.D. or related degree in life sciences with a minimum of 1 year of clinical molecular diagnostics experience; or
M.Sc. in life sciences with a minimum of 2 years of clinical molecular diagnostics experience; or
B.Sc. in life sciences with a minimum of 3 years of clinical molecular diagnostics experience.
Work experience in regulated products is highly desired; for example, FDA approved In Vitro Diagnostic devices, PMA or 510(k) submissions, QSR and Design Control, and CLIA/CAP and NYSDOH compliance, especially in verifications and validations.
Strong scientific expertise and knowledge base in molecular diagnostic testing.
Excellent written and oral communication skills.
Proven ability for cross-functional work and meeting project timelines.
The ability to work independently and function as a leader is highly desired.

About UsMyriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on three strategic imperatives: maintaining leadership in an expanding hereditary cancer market, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. For more information on how Myriad is making a difference, please visit the Company's website: www.myriad.com .

WE ARE AN EQUAL OPPORTUNITY EMPLOYER. Applicants and employees are considered for positions and are evaluated without regard to mental or physical disability, race, color, religion, gender,national origin, age, genetic information, military or veteran status, sexual orientation, marital status or any other protected Federal, State/Province or Local status unrelated to the performance of the work involved.

Please answer all questions completely. Please do not provide any information not specifically requested on this Employment Application form.



Posted: 2020-09-10 Expires: 2020-10-11

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Assoc Scientist I

Myriad Genetics, Inc
Salt Lake City, UT 84101

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