Project Manager, Regulatory Intelligence

3 weeks ago

St Paul, United States TechLink Systems Full time

Job Description

Job Description

Job Title: Project Manager I Location: St. Paul, MN (ONSITE) Pay rate: $70 - $75 an hour Contract Duration: 11 months contract to start Working Hours: 8am - 5pm

Description: Project Manager, Regulatory Intelligence Primary Focus: EUMDR

Responsible for project management for Abbott Medical Devices implementation of EUMDR, through the final stages for EU certification, and our 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.

Responsibilities include: • 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

Ideal candidate: Has led several mid-to high projects of varying complexity from beginning to end. Can convey tangible program management skills and effective judgement 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 a plus. Experience project managing processes supported with IT systems, data functionality, and external or internal business requirements a plus.

Required: 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. Company Description Overview

TechLink Systems is a national provider of staffing services with offices all over the USA as well as development and support centers globally. We are a MBE (NMSDC), WBE (WBENC), and WOSB certified minority business that has been awarded 2017 TAPFIN Premier Partner, 2016 Manpower Excellence Award, 2016 TAPFIN Elite Partner, are a Known Tier Supplier for Agile 1, and have been ranked as a Top Women and Minority Owned Company since 2004 by several businesses including Philadelphia Business Journal, Diversity Business, Inc 5000, Inc 500, San Francisco Business Times, Diversity2000, and Los Angeles Business Journal.

We serve the contract staffing, direct hire, staff augmentation, recruitment, HR management, and project outsourcing needs of clients nationwide. Striving to create personal relationships with clients, TechLink Systems becomes a virtual extension of clients’ own in-house capabilities to help achieve new levels of growth, productivity, and competitiveness.

We also have national recruiting centers that service our enterprise and MSP/VMS clients. We are a Secret Cleared Facility and our core competencies are Information Technology, Engineering, Customer Service/Call Center, Admin/Clerical,

Finance/Accounting,

Scientific/Clinical,

Sales/Marketing, Legal, Human Resources, Light Industrial (limited), and Professional across a range of industries.

The company’s talented Recruiters and HR Specialists have backgrounds in many cutting-edge, high-performance industries making TechLink Systems an ideal partner for recruitment process outsourcing.

We look forward to our partnership with you

Company Description

Overview\r\rTechLink Systems is a national provider of staffing services with offices all over the USA as well as development and support centers globally. We are a MBE (NMSDC), WBE (WBENC), and WOSB certified minority business that has been awarded 2017 TAPFIN Premier Partner, 2016 Manpower Excellence Award, 2016 TAPFIN Elite Partner, are a Known Tier Supplier for Agile 1, and have been ranked as a Top Women and Minority Owned Company since 2004 by several businesses including Philadelphia Business Journal, Diversity Business, Inc 5000, Inc 500, San Francisco Business Times, Diversity2000, and Los Angeles Business Journal. \r\rWe serve the contract staffing, direct hire, staff augmentation, recruitment, HR management, and project outsourcing needs of clients nationwide. Striving to create personal relationships with clients, TechLink Systems becomes a virtual extension of clients’ own in-house capabilities to help achieve new levels of growth, productivity, and competitiveness. \r\rWe also have national recruiting centers that service our enterprise and MSP/VMS clients. We are a Secret Cleared Facility and our core competencies are Information Technology, Engineering, Customer Service/Call Center, Admin/Clerical, Finance/Accounting, Scientific/Clinical, Sales/Marketing, Legal, Human Resources, Light Industrial (limited), and Professional across a range of industries. \r\rThe company’s talented Recruiters and HR Specialists have backgrounds in many cutting-edge, high-performance industries making TechLink Systems an ideal partner for recruitment process outsourcing.

\r\rWe look forward to our partnership with you #J-18808-Ljbffr

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