Kelly Services Clinical Data Quality/RAD Analyst in Raynham, Massachusetts
Clinical Data Quality/RAD Analyst
Kelly Services is currently seeking a International Regulatory Affairs Coordinator for a long-term engagement with one of our Global Pharmaceutical clients.
This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.
License Data Quality (RAD) Analyst will investigate licensing data within the MDRIM “Medical Device Regulatory Information Management” system. Entering approval data for release or restriction requirements within the RAD “Regulatory Approval Database”. Analyst will track and manage their workload through the RAD team’s systems/processes, ensuring high attention to detail and quality of work.
To enter product approval requests into the RAD “Regulatory Approval Database” enabling product release to Worldwide Markets, whilst maintaining complete regulatory compliance. Analysts are responsible to investigate and execute the entry of registration data into the RAD system.
RAD Analysts act as a secondary reviewer of the regulatory approval data held in MDRIM., ensuring license and product information is correct and accurate per country regulations.
Update request tracking to ensure the workload is documented accurately throughout the investigation process.
Enters and maintains regulatory approvals/restrictions in the RAD system.
Performing special projects as required.
Facilitate registration approval investigations as required.
Perform other duties as assigned.
A Bachelor’s degree is required.
Medical Device and/or Pharma experience is preferred.
Basic working knowledge of FDA and/or European regulatory requirements is preferred.
International experience outside of the US and EU is an asset.
Tableau, Power BI, Alteryx, or other systems tools experience is an asset.
The ability to develop and maintain excellent working relationships with regulatory, supply chain, and other external departments is required.
Ability to write, proofread and check documents for accuracy; relate information to requirements; and identify inconsistencies will be required.
Proficiency in the use of MS Office Software including Sharepoint, word processing, spreadsheet and Database analytics will be required.
Excellent communication, organizational, problem-solving, and critical thinking skills are required.
Must be able to work successfully within a team environment and as an individual contributor.
Primary responsibility and daily routine:
Review medical device global registration data
Utilize tableau generated reports to identify changes/additions in registration information in the MDRIM application
Assign tasks to team members through a request management tracker for processing in the RAD application
Review country licenses and ensure alignment with any/all local regulatory requirements
Release/restrict products in the RAD application that are compliant for distribution
Liaise with various business functions and all levels of leadership as needed
Liaise with global regulatory partners to ensure license quality and business continuity
Partner with License Data Quality/RAD core team members to help oversee the management of the RAD and MDRIM applications
Provide regular input, guidance, and solutions for various RAD/MDRIM/system related challenges and other side projects
You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.
Why Kelly ® ?
Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.
About Kelly ®
At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)