ARUP
PharmaDx Quality Project Manager
ARUP, Salt Lake City, Utah, United States, 84193
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. This position works with limited supervision with wide latitude for independent judgment and decision making.
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.
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.
Prepares and conducts training for GMP, GCP, GLP requirements.
Manages the quality assurance and regulatory aspects of ARUP projects.
Works closely with each project team to implement Design Control, GCLP, or other applicable principles.
Supports the PharmaDx Quality and Regulatory Affairs Manager in implementing strategic goals for the department.
Represents the PharmaDx quality and regulatory affairs teams on change controls.
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.
Sedentary Work: Exerting up to 10 pounds of force occasionally.
Fine Motor Control: Picking, pinching, typing or otherwise working with fingers.
Vision: Having close, far, and peripheral visual acuity.
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
Education
Required
Bachelor's Degree or better in Biological Sciences or related field
Licenses & Certifications
Preferred
Applicable ASQ
Regulatory Affairs Cert
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
#J-18808-Ljbffr
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. This position works with limited supervision with wide latitude for independent judgment and decision making.
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.
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.
Prepares and conducts training for GMP, GCP, GLP requirements.
Manages the quality assurance and regulatory aspects of ARUP projects.
Works closely with each project team to implement Design Control, GCLP, or other applicable principles.
Supports the PharmaDx Quality and Regulatory Affairs Manager in implementing strategic goals for the department.
Represents the PharmaDx quality and regulatory affairs teams on change controls.
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.
Sedentary Work: Exerting up to 10 pounds of force occasionally.
Fine Motor Control: Picking, pinching, typing or otherwise working with fingers.
Vision: Having close, far, and peripheral visual acuity.
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
Education
Required
Bachelor's Degree or better in Biological Sciences or related field
Licenses & Certifications
Preferred
Applicable ASQ
Regulatory Affairs Cert
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
#J-18808-Ljbffr