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

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