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.

Responsibilities:

  • 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

  • Complaint determination

  • Reportability assessments

  • Conduct follow-ups with complainant, reporters

  • Checking your own work

  • Updating SharePoint

  • Tracking complaints in the process for closure

  • All other duties assigned

Requirements:

  • 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

  • Detail orientation

  • Organization 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)

  • Continuous learner

  • Global mindset

  • Accountability for own work

  • Problem solving/root cause analysis skills

Why Kelly?

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*

Apply today!

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