Regulatory Compliance Specialist

3 weeks ago


Chaska, Minnesota, United States Compunnel Full time
Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist to support our IA business unit in meeting global registration requirements.

Key Responsibilities
  • Interpret federal/state/international regulations as they apply to our products, processes, and procedures.
  • Advise on the impact of regulations and devise strategies for compliance.
  • Liaise with regulatory bodies, investigate and resolve compliance problems, and audit current policies and procedures for compliance.
  • Determine the need for and prepare regulatory submissions, negotiate the resolution of agency questions, and secure market clearance and/or approval.
  • Respond to regulatory agency inquiries and maintain regulatory files.
  • Communicate with internal technical and regulatory personnel, interpret and evaluate data, and write and edit technical documents.
Requirements
  • Knowledge of product history, profile, specifications, standards, safety issues, precedents, and approval.
  • Ability to investigate regulatory history, meet and follow policies and procedures, and communicate effectively with internal stakeholders.
  • Experience with electronic submission processes, types, and requirements, as well as import/export requirements.
  • Ability to evaluate design changes for regulatory filing strategies and assess regulatory impact and risk.
What We Offer

As a Regulatory Affairs Specialist at Compunnel, you will have the opportunity to work with a dynamic team and contribute to the success of our IA business unit.



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