Regulatory Affairs Specialist

My client is a global leader in specialty dental devices and equipment.  They are seeking a Regulatory Affairs Specialist to provide regulatory guidance and assistance at all phases of the product lifecycle.  This includes registering products globally, monitoring regulatory compliance, maintaining required regulatory records, and interacting with regulatory agencies.  It’s an exciting time to join this stable, growing company and help them to get new devices approved around the world.

Responsibilities:

  • Creation and implementation of regulatory strategies to support the development of new and revised medical device products.
  • Register new products with US and international health agencies and maintain the registrations of existing products according to the applicable regulatory strategies.
  • Provide guidance to the Engineering staff on the creation and maintenance of Design History Files (DHF), Device Master Records (DMR) and Technical Files.
  • Provide technical assistance to other departments in the determination of testing requirements to comply with medical device and electrical safety regulations.
  • Assist in establishing and maintaining regulatory functions and systems to ensure continuous medical device and environmental regulatory compliance.
  • Assist in maintaining the Quality Management System to ensure domestic and international standards are met.
  • Define and document corporate regulatory practices within the Quality Management System to maintain compliance with applicable regulatory agencies.
  • Analyze complaints regularly for trends to determine improvements to Design and Safety.
  • Evaluate adverse event complaints that may need reported to applicable agencies.
  • Interface with cross-functional teams on large and small projects to ensure products are transferred to production in accordance with cGMPs, QSRs, MDRs and the Quality Management System.

 

Knowledge and Skills:

  • Bachelor’s degree in a science, mathematics, engineering or other technology field is required
  • 1-3 years of progressive experience in regulatory affairs required; experience with medical device products preferred
  • Strong knowledge of US FDA regulations; 21CFR 820, ISO13485 and MDD QMS requirements preferred
  • Experience working with Health Canada, Europe and ROW a big plus
  • ASQ, Six Sigma, RAPS or other regulatory certifications preferred
  • Proficient in Microsoft Office Suite (Word, Excel, Project, Visio, Power Point, Outlook)
  • Problem solving/analysis including statistical process control
  • Technical capacity including decision making, communication and reporting
  • Strong interpersonal communication skill set

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