University of Utah Regulatory Affairs Associate in Salt Lake City, Utah
Open Date 01/14/2019
Requisition Number PRN19362B
Job Title Project Administrator
Working Title Regulatory Affairs Associate
Job Grade F
FLSA Code Administrative
Patient Sensitive Job Code? No
Standard Hours per Week 40.00
Full Time or Part Time? Full Time
Work Schedule Summary
VP Area U of U Health - Academics
Department 01504 - Center For Medical Innovations
City Salt Lake City, UT
Type of Recruitment External Posting
Pay Rate Range 47600 to 70000
Open Until Filled Yes
The Regulatory Affairs Associate will support the operations, and strategic planning for regulatory and quality consulting for start-up lifescience based companies coming out of the multifaceted areas or departments within the University and industry. Supports the pre-market regulation process for products requiring governmental action before they can be placed on the market, including filing necessary applications and handling regulatory agency interactions, in particular, but not limited to, USFDAand Notified Bodies. Assists in 3rd party audits of the organizations and contract facilities, and assists in developing procedures to ensure regulatory compliance.
•Supports senior regulatory personnel in preparing documents necessary for new product market submissions during product life cycle management that includes, but not limited to, 510Ks, and technical files for CE marking
•Coordinates additional information inquiries during the governmental review process and provides the additional information to the governmental body.
•Develops the regulatory strategy for companies.
•Maintains Regulatory Affairs documentation
•Well versed/knowledgeable in the aspects of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements
•Assist in the preparation of procedures to ensure compliance with Regulatory requirements
•Participates in internal quality audits as well as suppler and contractor audits, as scheduled.
•Performs on special projects as required
•Ability to plan and schedule multiple priorities in a concurrent fashion
•Excellent problem solving and analytical skills
•Complete work with minimal supervision and ability to work independently
•Ability to work well with start-ups teams
•Support small start-ups through all phases of product development;
•Actively reviews and edits documents associated with product development,
•Remain current on developments in field(s) of expertise, regulatory requirements, and industry trends.
•Ability to review, collate and summarize scientific and technical data
•Strong oral and written communication skills, as well as the ability to provide scientific presentations, including occasional teaching.
•Hands-on, action-oriented, Continuous improvement minded; familiar with balancing the need for Quality and the need for efficiency
Bachelor’s degree in Business Administration, Accounting, or a related field, or equivalency; four years of progressively more responsible related experience; and demonstrated human relation and effective communications skills required. A related Master’s degree preferred.
•Bachelor’s degree in Life or Engineering Science, Business, or equivalency with at least a basic working knowledge in Medical Devices, primarily in the area of regulatory affairs and quality,
•Applied experience with 510(k) submissions,
•ISOregulated environment or equivalent training,
•Working knowledge ofISO13485,ISO14971,FDAregulations andMDD/MDR,
•Good writing and strong organizational skills required,
•Demonstrated communication and human relation skills,
•This position is in an office environment and requires the incumbent to perform general office functions. The ideal candidate must be able to work with small to medium sized start-ups in a fast paced environment,
•This position has no responsibility for providing care to patients.
Type Benefited Staff
Special Instructions Summary
The University of Utah is an Affirmative Action/Equal Opportunity employer and is committed to diversity in its workforce. In compliance with applicable federal and state laws, University of Utah policy of equal employment opportunity prohibits discrimination on the basis of race or ethnicity, religion, color, national origin, sex, age, sexual orientation, gender identity/expression, veteran’s status, status as a qualified person with a disability, or genetic information. Individuals from historically underrepresented groups, such as minorities, women, qualified persons with disabilities, and protected veterans are strongly encouraged to apply. Veterans’ preference is extended to qualified applicants, upon request and consistent with University policy and Utah state law.
To inquire about this posting, email: firstname.lastname@example.org or call 801-581-2300. Reasonable accommodations in the application process will be provided to qualified individuals with disabilities. To request an accommodation or for further information about University AA/EO policies, please contact the Office of Equal Opportunity and Affirmative Action, 201 S. Presidents Cr., Rm 135, (801) 581-8365 (V/ TDD ), email: email@example.com .
The University is a participating employer with Utah Retirement Systems (“URS”). Eligible new hires with prior URS service, may elect to enroll in URS if they make the election before they become eligible for retirement (usually the first day of work). Contact Human Resources at (801) 581-7447 for information. Individuals who previously retired and are receiving monthly retirement benefits from URS are subject to URS’ post-retirement rules and restrictions. Please contact Utah Retirement Systems at (801) 366-7770 or (800) 695-4877 or University Human Resource Management at (801) 581-7447 if you have questions regarding the post-retirement rules.
This position may require the successful completion of a criminal background check and/or drug screen.
The University is a participating employer with Utah Retirement Systems (“URS”). Eligible new hires with priorURSservice, may elect to enroll inURSif they make the election before they become eligible for retirement (usually the first day of work). Contact Human Resources at (801) 581-7447 for information. Individuals who previously retired and are receiving monthly retirement benefits fromURSare subject to URS’ post-retirement rules and restrictions. Please contact Utah Retirement Systems at (801) 366-7770 or (800) 695-4877 or University Human Resource Management at (801) 581-7447 if you have questions regarding the post-retirement rules.This position may require the successful completion of a criminal background check and/or drug screen.