Top 12 Regulatory affairs Jobs in Bluffdale, Ut

PharmaDx Regulatory Affairs Specialist I
ARUP —Salt Lake City, UT
- Monday to Friday
- Microsoft Word
- Microsoft Excel
- Office
11d
Regulatory Specialist
University of Utah Health —Salt Lake City, UT
- $62,004 - $92,678 a year
- Full-time
- Pass drug screening
- Mid-level
- Master's degree
- AD&D insurance
- Paid holidays
Product Compliance & Regulatory Affairs Manager
Pestie —Bluffdale, UT
- Full-time
- 5 years
- Office
- Analysis skills
- Relocation assistance
- Dental insurance
Quick Apply
Regulatory Specialist
University of Utah —Salt Lake City, UT
- Full-time
- Pass drug screening
- Mid-level
- Master's degree
- AD&D insurance
- Paid holidays
Data Coordinator
START Center for Cancer Research —West Valley City, UT
- Monday to Friday
- Mid-level
- High school diploma or GED
- Bachelor's degree
- Health savings account
- Paid holidays
Quick Apply
6d
Product Compliance Analyst
RED CAT HOLDINGS —Salt Lake City, UT
- Remote
- Background check
- Mid-level
- Ability to lift 50 pounds
Regulatory Permitting Specialist
Rainmaker Technology Corporation —Salt Lake City, UT
- $100,000 - $120,000 a year
- Bachelor's degree
- Continuous improvement
- Travel
Quick Apply
Senior Supervisor, Laboratory
University of Utah —Salt Lake City, UT
- $60,000 - $70,000 a year
- Full-time
- Computer Science
- Pass drug screening
- Master's degree
- Retirement plan
12d
Senior Supervisor, Laboratory
University of Utah Health —Salt Lake City, UT
- $60,000 - $70,000 a year
- Full-time
- Computer Science
- Pass drug screening
- Master's degree
- Retirement plan
12d
NERC Operations Sr Analyst, East
AES Corporation —Salt Lake City, UT
- $83,000 - $99,450 a year
- Full-time
- Engineering
- Research
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
NERC Operations Sr Analyst, Central
AES Corporation —Salt Lake City, UT
- $83,000 - $99,450 a year
- Full-time
- Engineering
- Research
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
NERC Operations Team Leader
AES Corporation —Salt Lake City, UT
- $108,500 - $135,575 a year
- Full-time
- 5 years
- Bachelor of Science
- Engineering
- Health insurance
- Dental insurance
Quick Apply

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PharmaDx Regulatory Affairs Specialist I

ARUP -
Salt Lake City, UT

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Job Details

11 days ago

Qualifications

Bachelor's degree
Pharmaceutical company experience

Full Job Description

Schedule:
Monday - Friday (40 hrs/wk)
8:00 AM - 5:00 PM

Department: PharmaDx - 511

Primary Purpose:

The PharmaDx Regulatory Affairs Specialist I supports the development and submission of lab developed tests and companion diagnostics (class III medical devices) to the FDA and other global regulatory bodies for in vitro diagnostic (IVD) approval and/or performance of clinical trials. The PharmaDx Regulatory Affairs Specialist I supports IRB/ethics approval applications, continuing reviews, and decisional support. The Specialist I has knowledge of Design Control and/or PharmaDx’s Product Development Program (PDP) and risk management. The Specialist I serves as regulatory affairs project support on product development teams, assists in supporting the proper implementation of PDP practices by project teams, and reviews PDP documents to ensure their suitability for regulatory filings. The Specialist I is also responsible for supporting preparation of communications to product sponsors and the FDA or other regulatory bodies, as needed. The Specialist I reports to PharmaDx Quality and Regulatory Affairs management.

About ARUP:

ARUP Laboratories is a national clinical and anatomic pathology reference laboratory and an enterprise of the University of Utah and its Department of Pathology. Based in Salt Lake City, Utah.

ARUP proudly hires top talent to create a work environment of diversity, professional growth and continuous development. Our workforce is committed to the important service we provide to over one million patients each month. We always strive for excellence and have a strong desire to have involvement with the advances in medicine and the role laboratory services plays within each patient’s life. We never forget that there is a patient behind every specimen we receive.

We are looking for individuals who want to contribute to ARUP's culture of accountability, integrity, service, and excellence. Consider joining our dynamic team.

Essential Functions

Uses working knowledge of applicable regulations and standards (e.g. ISO, FDA, IVDD/IVDR, CAP/CLIA, GMP, GCP, and other global standards) to contribute to project teams that develop and seek approval for companion diagnostic tests and to support clinical trials.

Supports the regulatory aspects of PharmaDx projects in order to meet requirements, timelines, and deliverables and to maintain compliance with applicable standards, regulations, and policies.

Assists in the preparation of regulatory submission documents for the FDA or other regulatory agencies (e.g., IRB, SRD, IDE, PMA, performance evaluation application, non-US technical dossier).

Works closely with project teams to implement Design Control, risk management, or other applicable principles, and supports associated regulatory submission processes, documents, and submission timelines.

Provides assistance to the project team for implementation of ARUP’s Design Control program as it relates to supporting a responsive and compliant regulatory submission package.

Possesses a working knowledge of Good Documentation Practices and design change control.

Supports authoring and review of PharmaDx policies and procedures to ensure compliance with FDA and other regulatory agencies.

May assist in supporting external audits by sponsors and regulatory authorities.

Supports regulatory-related responses on supplier qualification questionnaires.

Participates in continuous improvement projects.

Supports PharmaDx Quality and Regulatory Affairs management, as needed.

May support onboarding of new team members.

Other duties as assigned.

Physical and Other Requirements:

Stooping: Bending body downward and forward by bending spine at the waist.

Reaching: Extending hand(s) and arm(s) in any direction.

Mobility: The person in this position needs to occasionally move between work sites and inside the office to access file cabinets, office machinery, etc.

Communicate: Frequently and effectively communicate with others.

PPE: Biohazard laboratory environment that requires use of personal protective equipment in accordance with CDC and OSHA regulations and company policies.

ARUP Policies and Procedures: To conduct self in compliance with all ARUP Policies and Procedures.

Sedentary Work: Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects.

Fine Motor Control: Picking, pinching, typing or otherwise working, primarily with fingers rather than with the whole hand as in handling.

Experience

Required

Bachelor’s degree in Medical Laboratory Science, Biology, Chemistry or equivalent degree
Two years of experience in pharmaceutical, IVD, or medical device industry working under design control

Preferred

1-2 years of experience in writing regulatory documents
Experience in Good Manufacturing Practice or Good Clinical Practice
Intermediate to advanced experience with Microsoft Word, Excel, and PowerPoint
Demonstrated strong organizational, problem-solving, troubleshooting, and interpersonal skills
One year of experience in regulatory affairs

Education

Required

Bachelor's Degree or better in Biological, Chemical, or Scientific Field or related field

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.

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Refine Your Search

regulatory affairs jobs in bluffdale, ut

PharmaDx Regulatory Affairs Specialist I

Regulatory Specialist

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Product Compliance Analyst

Regulatory Permitting Specialist

Senior Supervisor, Laboratory

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