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Kelly Services Regulatory Affairs II (Reg II) in Lenexa, Kansas

Kelly Science and Clinical has a position available in the greater Kansas City area with a chemical manufacture.

Regulatory Compliance Specialist - direct hire job opportunity

We are looking for a candidate with at least five years of FDA & ISO 9001 experience

preference also given to someone with Medical Device, FDA submissions and Specialty Chemicals

SPECIFIC JOB DUTIES:

Regulatory Calendar Management

Establish, manage, and maintain a comprehensive calendar of regulatory events and filings.

Manage internal communication of key regulatory events to ensure timely response from other functions as required.

Licensing and Registrations:

Coordinate and maintain status of federal and state level EPA registrations working with outside consultants as needed.

Act as the primary point of contact for internal and external requests related to current regulatory registrations and licensing status. Log all requests (internal and external) noting when copies of certifications and registrations are requested/provided.

Review and document (as needed) the certifications, registrations, licensing of Suppliers and Contract Manufacturers when required as part of a Manufacturing Services Agreement or Quality Agreement with Supplier.

Regulatory Submissions:

Support development of all regulatory submissions consistent with guidance provided by the regulating body (e.g. EPA, FDA, UL) seeking input throughout the organization as needed to fulfill submission requirements.

As the first point of contact for agency interactions, manage follow-on requests to the point of satisfactory submission closure.

Provide review/sign-off of all product labeling and Marketing materials prior to release into the Quality Management System.

Regulatory Systems Development

Establish consistency in the Regulatory function through develop of SOPs, Work Instructions, Forms/Templates as required to document standard Regulatory processes

Management Review

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/non-traditional 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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