Project Manager-Regulatory Affairs

Considering candidates for Onsite, Hybrid or Remote; living in the Salt Lake City Region or Utah is preferred as there are meetings & certain work that will need to be accomplished onsite and in-person as a team...

Overview

The Project Manager, Regulatory Affairs is responsible for overseeing and managing project activities related to and impacting the Regulatory Affairs department. The role involves but is not limited to participation in planning of major projects, tracking and reporting on regulatory related activities, and coordinating the completion of activities to minimize disruption to project plans. This role will work closely with department staff and cross-functional teams to ensure alignment of activities and timelines while establishing the appropriate work prioritization.

The position works across all departments and demands a dynamic individual with excellent inter-personal skills. Solid technical writing skills, strong organizational skills, communication and attention to details are required.

Responsibilities

Tracks and reports on regulator related projects, activities, and tasks internal to the regulatory department and external to the appropriate stakeholders.

Plans, coordinates and delivers assigned project/product activities, including, but not limited to, project/product regulatory plans and providing strategic/tactical guidance.

Works closely with intra and inter department management to estimate work effort, required resources and task scheduling to ensure overall project goals are met on time.

Serve as a lead contact with internal and external stakeholders with a primary focus on regulated products.

As assigned, lead and/or participate in design control, labeling and promotional document and other related quality, regulatory and compliance activities.

Qualifications

Minimum of BS degree, MS preferred in a technical field, i.e. sciences or engineering.

Minimum of 5 years (7 for higher level) project management experience, preferably in the in vitro diagnostic (IVD), engineering and/or quality function(s) with demonstrated ability to lead and influence others in a matrix environment.

Working knowledge of Quality Systems Regulations (21 CFR 820), CLIA and related regulations.

Project management certification (PMP) preferred.

Strong interpersonal and communication skills required.​

​​​​​​​ Ability to interact positively and provide guidance within all levels of management and staff.

Physical & Lifting Requirements

Lifting Requirements - medium work or exerting up to 50 pounds of force occasionally, 20 pound of force frequently, and 10 pounds of force consistently.

Physical Requirements - stationary positioning, moving, operating, ascending/descending, communicating, observing, reaching and repetitive motion.

Use of equipment and tools necessary to perform essential job functions.

Hazards and Atmospheric Conditions - exposure to fumes, dust, extreme temperatures, wet and/or humid, noise, vibration, mists or gases, mechanical hazards, chemical hazards, electrical hazards and radiant energy hazards. OSHA Category I - duties performed routinely requires exposure to blood, body fluid and tissue.