Description

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

Department: PharmaDx - 506

Primary Purpose :

The PharmaDx Quality and Regulatory Affairs Project Manager supports the development and submission of companion diagnostics (class III medical devices) to the FDA and other regulatory bodies for approval and/or supports the PharmaDx quality management System (QMS). The PharmaDx Quality and Regulatory Affairs Project Manager creates, gathers, and compiles the regulatory documentation to support medical device submissions. The PharmaDx Quality and Regulatory Affairs Project Manager researches regulatory requirements to support device development or clinical trial planning for FDA, EU IVDR, PMDA, or other regulatory bodies. The Quality and Regulatory Affairs Project Manager also supports the PharmaDx QMS to ensure compliance with GMPs, GCPs and GLPs. The Quality and Regulatory Affairs Project Manager will organize and coordinate trainings, maintain the internal and external audit schedules, host audits and regulatory inspections, and approve on audit reports. The Quality and Regulatory Affairs Project Manager has in depth knowledge of ARUP’s Product Development Program (PDP), US and international regulations. This position works with limited supervision with wide latitude for independent judgment and decision making.

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 (i.e. ISO, FDA, IVDR, CAP/CLIA, GMP, PMDA, ROW standards, etc…) to contribute to the development and approval of companion diagnostic tests, management of clinical trials and compliance with PharmaDx QMS.

Possesses a strong working knowledge of ARUP’s PDP including ARUP’s processes for design control and change control.

Authors and reviews PharmaDx policies and procedures to ensure compliance with FDA, EU IVDR, PMDA and other regulatory agencies requirements.

Provides guidance to the project team for implementation of ARUP’s PDP and international device requirements.

Researches regulatory requirements to support device or clinical trial development.

Facilitates and independently writes and edits documentation for design control outputs to ensure all documents meet ARUP policies and international regulatory requirements.

Organizes and manages the timelines and deliverables for regulatory submission documents for the FDA, EU Competent Authorities, PMDA or other regulatory agencies.

Supports deviation or nonconforming product investigations. This may include leading the investigation, participating in root cause analysis, or implementing corrective/preventive actions.

Prepares for and participates in audits or inspections from sponsors and regulatory authorities and manages the preparation of audit responses.

Manages the external supplier audits and internal audit schedules and ensures audits are executed in compliance with PharmaDx SOPs and regulatory requirements.

Prepares and conducts training for GMP, GCP, GLP requirements for the department or project teams.

Manages the quality assurance and regulatory aspects of ARUP projects in order to meet requirements, timelines and deliverables and to maintain compliance with applicable standards, regulations and policies.

Works closely with each project team to implement Design Control, GCLP, or other applicable principles and manages associated processes and documents.

Supports the PharmaDx Quality and Regulatory Affairs Manager in implementing strategic goals for the department.

Represent the PharmaDx quality and regulatory affairs teams on change controls.

Supports the PharmaDx Quality and Regulatory Affairs Manager as needed.

Creates new processes and procedures, as applicable.

Trains employees and other PharmaDx Quality and Regulatory Affairs Specialists in quality and regulatory affairs activities.

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.

Vision: Having close, far, and peripheral visual acuity to perform a variety of tasks such as make general observations of depth and distance.

Qualifications

Education

Required

• Bachelor's Degree or better in Biological Sciences

Licenses & Certifications

Preferred

• Applicable ASQ

• Regulatory Affairs Cert

Experience

Required

• Bachelor’s degree in Medical Laboratory Science, Biology, Chemistry or related field

• Four (4) years of experience in pharmaceutical, IVD, or medical device industry with a focus on quality or regulatory affairs

Preferred

• Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society or American Society for Quality (ASQ) Certification in Six Sigma, Auditing or similar discipline

• Experience in companion diagnostics

• Two (2) years of experience in writing study protocols and other regulatory documents preferred

• Intermediate to advanced experience with Microsoft Word, Excel, and PowerPoint

• Demonstrated strong organizational, problem solving, troubleshooting, and interpersonal skills

• Experience in Good Manufacturing Practices, Good Laboratory Practice and/or Good Clinical Laboratory Practice

• Excellent written and oral communication skills

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)