Regulatory Affairs Associate II

11 hours ago

Salt Lake, Utah, United States Myriad Genetics Full time
Description

The Regulatory Affairs Associate II supports the development, implementation, and management of the department programs, ensuring compliance with applicable agencies and standards. Interacts with individuals at most position levels with occasional contact with representatives from external regulatory agencies to further collaboration. Leads activities related to regulatory affairs both domestically and internationally, working closely with internal teams. Works closely with various departments in coordinating document/records management along with completing administrative tasks.

Responsibility

  • 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.

Qualifications

  • 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.)

Physical Requirements

Lifting Requirements – light work or exerting up to 20 pounds of force frequently. Physical Requirements – stationary positioning, moving, operating, ascending/descending, communicating, observing, pushing or pulling, and reaching. Use of equipment and tools necessary to perform essential job functions.

EEO

We recognize that our people are our strength and the diverse talents they bring to our global workforce are directly linked to our success. We are an equal opportunity employer and place a high value on diversity and inclusion at our company. In hiring and all other employment decisions, we prohibit discrimination and harassment on the basis of any protected characteristic, including race, religion, color, national origin, gender, sexual orientation, gender identity, gender expression, age, marital or veteran status, pregnancy or disability, or any other basis protected under applicable law. In accordance with applicable law, we make reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as any mental health or physical disability needs.

#LI-MH1

#LI-hybrid


  • Medical Affairs Manager IPD

    4 days ago

    Salt Lake, Utah, United States BD Full time $130,400 - $215,200

    Job Description SummaryThis position has the responsibility to provide medical and scientific input in support of the Infusion Preparation and Delivery Business Group initiatives.This role provides medical and clinical input as it pertains to new product development activities, marketing initiatives, quality assurance and regulatory product requirement...

  • Engineering Specialist II

    1 week ago

    Salt Lake, Utah, United States State of Florida Full time

    Requisition No: Agency: Military AffairsWorking Title: Engineering Specialist II Pay Plan: Career ServicePosition Number: Salary:  $45,060.11 Posting Closing Date: 11/28/2025 Total Compensation Estimator ToolDepartment of Military Affairs*** OPEN COMPETITIVE***APPLICATION DEADLINE: 11:59 p.m. on closing dateVACANCY # WORK LOCATION:  STARKE, FLABOUT THE...

  • Registered Nurse

    2 weeks ago

    Salt Lake, Utah, United States US Department of Veterans Affairs Full time $74,113 - $136,440 per year

    SummaryThe Utilization Management (UM) Registered Nurse (RN) executes position responsibilities that demonstrate leadership, experience, and creative approaches to management of complex utilization processes. Practical experience in the application of UM methods and expertise in medical necessity review criteria. This position requires strong analytical...

  • Nuclear Regulatory Technical Coordinator

    2 weeks ago

    Salt Lake, Utah, United States State of Utah Full time $60,000 - $90,000 per year

    *Job Description*The Department of Environmental Quality is looking to fill a Nuclear Regulatory Technical Coordinator (Environmental Engineer) position in the Division of Waste Management and Radiation Control. This position may be filled at any of the advertised levels listed below. Salary depends on experience and the job level offered within the...

  • Postmarket Surveillance Specialist II

    2 weeks ago

    Salt Lake, Utah, United States bioMerieux Full time $60,000 - $90,000 per year

    DescriptionPosition Summary:This position focuses on adverse event reporting. The position will be responsible for evaluation, preparation, implementation, and monitoring of vigilance reporting. The position may also support field actions activities, including evaluation, preparation, implementation and health authority reporting. Primary Duties: Support...

  • PS Regulatory Coordinator

    11 hours ago

    Salt Lake, Utah, United States University of Utah Full time

    DetailsOpen Date10/21/2025Requisition NumberPRN43374BJob TitlePS Regulatory CoordinatorWorking TitlePS Regulatory CoordinatorCareer Progression TrackETrack LevelFLSA CodeAdministrativePatient Sensitive Job Code?YesStandard Hours per Week40Full Time or Part Time?Full TimeShiftDayWork Schedule Summary40 hours per week; availability Monday through Friday, 7:30...

  • Registered Nurse

    2 weeks ago

    Salt Lake, Utah, United States US Department of Veterans Affairs Full time

    SummaryThe Registered Nurse Diabetes Educator Primary Care is responsible for providing competent, evidence-based diabetes education to staff and patients. S/he will provide educational instruction and training for diabetic patients, and serve as a resource for Primary Care staff to provide comprehensive education to Veterans. S/he will collaborate with...

  • Registered Nurse

    1 week ago

    Salt Lake, Utah, United States US Department of Veterans Affairs Full time

    SummaryThe Acute Medicine Registered Nurse (RN) is responsible for providing competent, evidence based care to assigned patients and oversight of licensed vocational nurses/nursing assistants, as appropriate to the setting. S/he will assist in directing the provision of nursing education, orientation, competencies and providing quality improvement and...

  • Registered Nurse

    2 days ago

    Salt Lake, Utah, United States US Department of Veterans Affairs Full time

    SummaryThe Cardiac Catheterization/Electrophysiology Laboratory (CCL) Registered Nurse (RN) is responsible for providing competent, evidence-based care which encompasses all aspects of pre/post and intra procedural care of patients undergoing procedures in the cath/EP labs. The cath lab nurse demonstrates a strong team approach to the nursing process as an...

  • Research Dev Associate II

    1 week ago

    Salt Lake, Utah, United States University of Utah Full time

    Applicants: use your skills in another way—work in a collaborative, positive Research Administration environment with the opportunity to develop project management, scientific writing, and leadership skills. Be part of a team dedicated to supporting Huntsman Cancer Institute, an NCI-designated Comprehensive Cancer Center, to maximize its potential,...