Kelly Services Customer Quality Regulatory Specialist in West Chester, Pennsylvania
Post Market Regulatory Affairs Specialist: West Chester, PA
Kelly Services is seeking a Post Market Regulatory Affairs Specialist for one of our top clients in West Chester, PA.
This is a 6 month contract assignment.
As a Post Market Regulatory Affairs Specialist placed with Kelly Services you will be responsible for supporting Post Market Regulatory Affairs activities associated with complaint handling and MDR submissions. These activities include intake, investigation, documentation, follow-up, regulatory reporting and metrics. The Regulatory Specialist is responsible for oversight and direct support of technical evaluations and investigational tasks required for complaint processing/closure. The Specialist works collaboratively with Quality, Engineering, Manufacturing, Product Development and other functional experts.
Responsible and accountable for on-time submission and accuracy of regulatory reports
Review and complete determination associated Medical Device Report and/or Vigilance Report
Knowledge of and familiarity with global regulations for reporting
Directly interface with service centers, Hospitals, Surgeons, and Internal employees for reporting of complaints and adverse events.
Interact positively with internal, external business partners and colleagues
Adhere and comply to work instructions, standard operating procedures, and regulations.
Expedite investigations by collaborating with internal/external business partners
Achieve productivity targets
Achieve accuracy targets for complaint documentations
Participate in projects and events
Conduct follow-ups with complainant, reporters
Checking your own work
Tracking complaints in the process for closure
All other duties assigned
Bachelor’s degree or equivalent experience
Generally requires 2 -4 years of related work experience
RAC or ASQ certification a plus
Ability to work in a cross-functional matrix environment
Active listening/phone skills
Collaboration and teaming skills
Critical thinking skills
Prioritization and multi-tasking skills
Strong verbal and written communication skills
Knowledge of basic medical terminology
Proficiency in MS Office (Word, Excel, Outlook, PowerPoint, Sharepoint)
Accountability for own work
Problem solving/root cause analysis skills
As a Kelly Services employee, you will have access to numerous perks, including:
Exposure to a variety of career opportunities as a result of our expansive network of client companies
Career guides, information and tools to help you successfully position yourself throughout every stage of your career
Access to more than 3,000 online training courses through our Kelly Learning Center
Weekly pay and service bonus plans
Group- rate insurance options available immediately upon hire*
Why Kelly ® ?
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm