Regulatory Affairs Specialist Job at KARDION, Irvine, CA

SDNzYWsxNk16RklYMTFTdm9rNDFNb0ZEVVE9PQ==
  • KARDION
  • Irvine, CA

Job Description

Title : Regulatory Affairs Specialist

Reports to : VP of Quality & Regulatory Affairs

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

Salary Range: $110,000 - $120,000 per year

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. You will join a small team who left great jobs to go “all in” with Kardion to bring a great product that they passionately believe in to market. Communication skills, humility, competitive spirit and team fit are paramount. 

The Regulatory Affairs Specialist is a key partner within Regulatory Affairs and will have responsibility of the direct execution of some corporate regulatory filings. This role will work independently on some submissions and partner with others in the Regulatory Team on other US FDA filings, including IDEs, 510(k)s and PMA. This position requires someone with both a strong execution mindset and ability to explain regulatory processes 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

  • Drive and author parts or whole regulatory submissions, including FDA IDEs, Q-Subs, 510(k)s and PMAs
  • Provide input and technical guidance on regulatory requirements to product development and operations teams
  • Support new product launch, risk management activities, regulatory plans, product V&V, process validations, and design transfer into manufacturing
  • Strategize and develop regulatory plans and documents for new products, product updates, manufacturing process changes, marketing materials, and clinical trials
  • Review and interpret regulatory rules as they relate to company products and procedures, clinical studies, testing or records keeping and ensure that they are communicated through company policies and procedures
  • Maintain present awareness of FDA and global regulations, guidance, and standards applicable to company products
  • Exercise good and ethical judgment within policy and regulations
  • Perform multiple tasks concurrently with accuracy
  • Provide guidance to functional groups in the development of relevant data to complete a regulatory submission
  • Other duties as assigned.

Skills, Qualifications & Key Knowledge Areas

  • Bachelor’s degree in engineering, science or related field or equivalent experience is required
  • Minimum of 5 year’s regulatory experience in a medical device firm is required
  • Experience drafting FDA 510(k)s and parts of PMA submissions is required
  • Experience with complex medical devices, incorporating electro mechanical and disposable components highly desired
  • Experience with interventional cardiology devices highly desired
  • Ability to exercise sound judgment and decision making 
  • Exceptional communication skills across functional areas and roles within organization 
  • Experience with remote team engagement required
  • Ability to travel both internationally and domestically, up to 20% at peak times

Job Tags

Local area, Remote job, Relocation,

Similar Jobs

Planet Forward

Office Services Technician Job at Planet Forward

*This is a 12-month contract* The individual MUST be able to work early on some mornings - 6:45AM and/or late evenings - 5:30PM - for event set-up & tear down (make sure candidate is aware of this). A Brief Overview The Office Services Technician position is responsible...

International Leadership of Texas

Food Service Worker Job at International Leadership of Texas

Primary Purpose: Responsible for on-site leadership of campus school nutrition operations. Daily Point of Sale duties, daily reconciliation, handling money, checking Production Records for accuracy, receiving goods, selling A la Carte items, and cleaning of area and equipment...

Academy of Real Estate Professionals

Adjunct Real Estate Instructor Job at Academy of Real Estate Professionals

 ...teach pre-license instruction, National portion for 60 hours, Live online. Ideal candidate can be remote, tech savy and have previous...  ...estate courses, providing instruction and guidance to students, and evaluating student performance. This is an remote position as needed.... 

Robert Half

Human Resources Generalist Job at Robert Half

The ideal candidate will be responsible for process improvement, driving new initiatives. Develop and ensure processes are in line to achieve goals. Strong employee relations, provide guidance and coaching. Developing and implement retention strategies. This position...

Upward Health

Virtual Care Specialist Job at Upward Health

: Upward Health is an in-home, multidisciplinary medical group providing 24/7 whole-person care. Our clinical team treats physical, behavioral, and social health needs when and where a patient needs help. Everyone on our team from our doctors, nurses, and Care Specialists...