MYRIAD GENETICS, INC. Regulatory Affairs Associate II (Remote/Hybrid) in SALT LAKE CITY, Utah

We are looking for a Regulatory Affairs Associate II to join our Regulatory Affairs team at Myriad Genetics. This position has the ability to be hybrid in Salt Lake City, UT or remote across the country. Please attach a cover letter for the position when completing the application. The Regulatory Affairs Associate II will report to the Sr Manager, Regulatory Affairs and assist with the development, implementation and ongoing management of the organization’s regulatory affairs compliance programs, to ensure compliance with applicable regulating agencies and align with industry standards. The Regulatory Affairs Specialist II will have interactions with individuals at most position levels within the organization and contact with representatives from external regulating agencies. The Regulatory Affairs Specialist II will operate as an integral member of the Regulatory Affairs team by leading certain regulatory affairs projects and furthering collaboration of the regulatory affairs programs, with emphasis in assigned areas of focus. The Regulatory Affairs Specialist II provides support and leads activities related to regulatory affairs both domestically and internationally, including coordination, development and maintenance of all regulatory submissions. The submissions will include but are not limited to Investigational Device Exceptions, Pre-Market Approvals, Supplements, Changes, six-month interval reports, annual reports, and regulatory submissions for other countries. This role works closely with the Quality and Compliance teams and various departments in coordinating document/records management along with completing some administrative tasks. The role also includes scheduling required submissions and providing assistance so that the submissions are prepared timely and accurately. Each employee’s specific job responsibilities are uniquely defined by their individual training plan and assigned duties, but are generally defined as follows: Responsibility

• Receives general instruction on routine work and detailed instructions on new projects or assignments. May provide guidance to lower level employees.
• Assists in the development and implementation of proactive programs to support the annual regulatory objectives and adherence to regulatory requirements and ethical behavior.
• Gathers regulatory information and provide suggestions for improvement to departmental management, if applicable
• Addresses common and easy problems with well understood solutions. Occasionally seeks guidance from others to find solutions and/or overcome obstacles
• Continually improves knowledge of current and pending revisions to regulatory compliance guidelines and safety requirements.
• Establishes and maintains a calendar for 6-month and annual reports to the domestic regulatory agencies and other global regulatory bodies. Schedules other required submissions such as 30-day pre-approvals for changes and helps to facilitate submissions.
• Tracks all pending submissions and provides assistance so that all… For full info follow application link. 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.

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