Regulatory Operations Specialist Job at KARDION, Irvine, CA

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  • KARDION
  • Irvine, CA

Job Description

Title: Regulatory Operations Specialist

Reports to: VP of Quality & Regulatory Affairs

Location: Remote initially then transitions to on-site (Irvine, CA office)

Salary Range: $38-41.00 per hour (Non-Exempt, $79,000 - $85,000 annualized)

Local candidates only; no relocation will be provided for this position.

The Kardion Regulatory Affairs team is seeking a high energy, driven individual who is looking for the unique opportunity and challenge provided by a clinical stage startup. We are looking for a highly organized professional who excels at tracking and coordination of regulatory submissions, and wants to bring those skills to Kardion. 

The Regulatory Operations Specialist is a key partner within Regulatory Affairs to enable the team as a whole to create high quality submissions in a timely manner. This position requires someone with the ability to gather information from a variety of sources, keep track of a wide variety of deliverables and communicate status to the organization. 

Position will initially be remote then transition to on-site when the Irvine, CA office location is available, mid-2025.

Essential Responsibilities

  • Submission content management and submission publishing for US markets
  • Ensure accurate reporting on status 
  • Track submission content creation
  • Optimize tools within team for efficiency in submission creation
  • Plan and implement publishing of submissions. 
  • Update regulatory processes and QMS procedures as needed
  • Maintain device listings, product licensing, and facility registrations
  • Provide audit support for FDA, NB, and international regulatory agency audits
  • Collaborate with cross-functional teams to prepare submission content and maintain overall regulatory compliance
  • Exercise good and ethical judgment within policy and regulations
  • Perform multiple tasks concurrently with accuracy
  • Other duties as assigned.

Skills, Qualifications & Key Knowledge Areas

  • Minimum of AA/AS in a scientific or business related field is preferred
  • Minimum of 3-4 years of experience in a Regulatory Operations role in the medical device industry
  • Experience with submission publishing, device listings, and UDI data collection and reporting
  • Familiarity with QMS updates and providing audit support for FDA, NB, and international agencies
  • Understanding of US and EU medical device regulations, including submissions, change notifications, and regulatory assessments
  • Experience with complex medical devices, incorporating electro mechanical and disposable components highly desired
  • Ability to exercise sound judgment and decision making 
  • Exceptional communication skills across functional areas and roles within organization 
  • Ability to travel both internationally and domestically, up to twice per year
  • Experience with remote team engagement required

Job Tags

Hourly pay, Local area, Remote job, Relocation,

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