REMOTE Global Regulatory Affairs Consultant

Company: GForce Life Sciences
Location: Saint Louis
Posted on: May 15, 2022

Job Description:

Consultant, Global RAQA, Medical Device
Summary
Our client, a medical device company that develops, manufactures, and markets robotic products has engaged GForce to identify a Regulatory Affairs consultant. This Regulatory Affairs consultant will work independently assuming primary responsibility for organizing OUS Regulatory data from multiple systems and consolidate the data in to Smartsheet. This person will be responsible for planning, directing, coordinating, and delivering project activities through the entire project lifecycle. This person will be responsible to lead project objectives and completion on time and will sometimes lead big projects with cross functional teams. This position will work to increase efficiency, motivate the team, and advocate for changes that will ensure the quality and timelines.

Duties / Expectations of Role
Help alleviate roadblocks with RAQA team by working with cross-functional teams
Work closely with other Project Managers to track tasks and deadlines and to keep RA team members accountable as well as cross-functional team members
Independently leads problem -solving and decision-making activities, within the scope of the project.
Facilitate communication with cross-functional teams and send routine correspondence by presenting and sharing regular updates.
Maintain /update regulatory databases, spreadsheets, project trackers etc., assuring that they are current and accurate
Work with IT to create and consolidate RAQA Dashboard in Tableau
Work with IT to create Data needed for QRB for Distributor CAPAs
Help manage and send out surveys to distributors and track results
Track and coordinate regulatory license renewals with timelines
Ability to work within a team and as an individual contributor in a fast- past changing environment.
Ability to leverage and engage others to accomplish projects within the RAQA team
Respond to other department requests as needed

Mandatory Requirements
B.S. degree or higher or equivalent experience
3+ years relevant experience working in a medical device company
Experience with regulatory, quality systems and compliance
3+ years of working as Project Manager.
Strong organizational and follow up skills, as well as attention to detail
Be able to solve complex problems within the area of responsibility for Indirect RAQA team that requires ingenuity and creativity
Good communication (written and oral) and organizational skills
Ability to perform multiple tasks in a fast-paced environment
Ability to prioritize and meet deadlines in a timely manner
Motivated to excel and work in a team environment
Understand implications of work and make recommendations for improvements in processes
Excellent skills in MS Word, Visio, Smart Sheet, Excel, and Outlook; capacity to learn additional software

Term & Start
6-month contract
Remote
Benefits (Medical, Dental, Vision, 401k)

Keywords: GForce Life Sciences, St. Louis , REMOTE Global Regulatory Affairs Consultant, Professions , Saint Louis, Missouri