Project Manager, Regulatory Intelligence

SMS Staffing Inc.

Saint Paul, MN

$72 Hourly
Full-Time

Job Description

SMS Staffing Inc is Hiring Immediately for a skilled Project Manager, Regulatory Intelligence!

Job Title: Project Manager, Regulatory Intelligence

Job Location: St. Paul, MN, U.S.A. 55117

Job Type: Contract (possible extension or convert to hire)

Pay: Starts at $72.00 an hour

Shift Structure: ONSITE, 8:00 AM - 5:00 PM, Monday to Friday, 40 hours per week

The role of the Project Manager, Regulatory Intelligence: Responsible for project management for Medical Devices implementation of EUMDR, through the final stages for EU certification, and International roll out. Plans and directs schedules. Monitors the program/project from initiation through delivery, interfacing with customers on process, regulation interpretation, technical matters, and integration into the Quality System. Drives completion of the program/project to deliver on schedule. Present program strategies and updates to executive management and stakeholders.

Work with IT and a cross businesses and functional teams to deliver processes necessary to support EUDAMED activities and integrate that into our quality systems
Collect, communicate, and ensure data accuracy in reporting project deliverable status
Provide direction on regulation ensuring accurate understanding and interpretation of requirements and their impact
Drive deliverables schedule based on established plans
As applicable, gather lessons learned and share best practices across the organization
Create and deliver project status report-outs (PowerPoint, Memo’s, meetings, etc.)
Effectively deliver and adjust messaging across all levels of the organization
Critical thinking and analysis used to identify, remove, and/or escalate roadblocks encountered
Creates a work environment that supports team effectiveness

About the Project Manager, Regulatory Intelligence:

The ideal candidate will have the following skills and experience:

Bachelor’s Degree in Engineering, life sciences or industrial technology preferred. Or an equivalent combination of education and work experience.
7+ years of experience in a project manager role preferred. Minimum of 3 years of experience required.
Has led several mid-to high projects of varying complexity from beginning to end.
Can convey tangible program management skills and effective judgment demonstrated by successful program results.
Outstanding communication skills.
Strong analytical skills.
Skills in using Excel and/or Power BI to communicate status of deliverables.
PMP Certification preferred.
Experience in a Regulated industry preferred.
Experienced with domestic and/or international regulations is a plus.
Experience project managing

Come join the SMS team! It takes more than top-notch facilities, modern equipment, and innovative technologies to become our customer’s most trusted supplier. It takes people who are committed to our customer’s success and who are willing to go the extra mile to get the job done right.