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