26 days old

Assoc Regulatory Affairs

Myriad Genetics, Inc
Salt Lake City, UT 84101
  • Job Code
    122949727
Location: Salt Lake City, UT, United States
Job Identification: 406
Job Schedule: Full time

The Regulatory Affairs Associate I will assist the Regulatory Affairs Director with the development, implementation and ongoing management of the organization's regulatory affairs programs, to ensure compliance with applicable regulating agencies and align with industry standards. The Regulatory Affairs Specialist I will have interactions with individuals at most position levels within the organization, and occasional contact with representatives from external regulating agencies. The Regulatory Affairs Specialist I will operate as an integral member of the Regulatory Affairs team, furthering collaboration of the regulatory affairs programs, with emphasis in assigned areas of focus.

The Regulatory Affairs Specialist I provides support for 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 helping to schedule required submissions and provide aids 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

1. Normally receives detailed instructions on all work.

2. Assists in the development and implementation of proactive programs to support the annual regulatory objectives and adherence to regulatory requirements and ethical behavior.

3. Helps to gather regulatory information and provide suggestions for improvement to departmental management, if applicable

4. Addresses common and easy problems with well understood solutions. Frequently seeks guidance from others to find solutions and/or overcome obstacles

5. Continually improves knowledge of current and pending revisions to regulatory guidelines and safety requirements.

6. Participates in establishing and maintaining a calendar for 6-month and annual reports to the domestic regulatory agencies and other global regulatory bodies. Assists in scheduling other required submissions such as 30-day pre-approvals for changes and help to facilitate submissions.

7. Supports tracking of all pending submissions and assists so that all submissions are executed in a timely fashion. Work with Document Control to load all submissions into Master Control for electronic approvals and long-term storage.

8. Helps to design and manage templates for cover letters, IDE, PMA, Application Forms, Summary of Technical Documentation (STED), Facility Registrations, Changes, and Supplements etc. so that the submissions will be standardized and have the appropriate language and content.

9. Helps to write and organize submissions with the appropriate templates to include table of contents, legal required language, appendixes, etc.

10. Additional duties as assigned by supervisor.

Qualifications

1. Bachelor's degree in Engineering, Life Science, or other technical discipline (or equivalent experience)

2. Zero to 3 years related professional experience in a regulated environment (preferably medical device).

3. Regulatory Affairs certification is preferred.

4. 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.

5. Strong research, analytical, and problem-solving skills.

6. Ability to set priorities and adapt to changing business needs and manage multiple assignments within established time frames.

7. Ability to work independently and on a team while filling various roles such as team member, etc.

8. Ability to efficiently use computer programs necessary to complete work requirements (MS Word, Excel, PowerPoint, etc.).

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.

PI122949727
Posted: 2020-08-25 Expires: 2020-09-25

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Assoc Regulatory Affairs

Myriad Genetics, Inc
Salt Lake City, UT 84101

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