Kelly Services Sr. Regulatory Affairs Specialist W/IVD Experience in Chaska, Minnesota
Kelly is currently seeking a Sr. Remote Regulatory Affairs Specialist w/IVD experience for a long-term engagement at one of our Global Pharma clients out of MN. This is a remote role so location should not be an issue
This role is a full-time, fully benefitted position. As a Kelly employee you will be eligible for Medical, Dental, 401K and a variety of other benefits to choose from. You’ll also be eligible for paid time off, including holiday, vacation, and sick/personal time.
As a Kelly Services employee, you will be responsible for planning, coordinating, facilitating, and reporting on regulatory programs.
The incumbent’s primary responsibilities will be the evaluation, coordination, preparation and implementation of pre-market Regulatory Affairs activities.
Responsibilities may include:
Administration and setup of template FDA and agency submissions for IVD projects.
Planning and implementing pre-market registration, reporting and compliance activities in accordance with the development center business plans.
Implementing global regulatory compliance programs for product corrective action and/or adverse event reporting.
Preparing premarket or other regulatory submissions (510(k), PMA, Technical Dossiers, etc.) for US and other governments.
Additionally, may provide assistance to technical departments, manufacturing business centers and suppliers in the creation and structuring of clinical data for pre-market notifications.
Bachelor’s degree in field with 5+ years exp. OR Master’s degree in field with 3+ years exp.
Medical Technologist background and IVD experience strongly desired.
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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. 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.
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