Control Regulatory Specialist

Position: Change Control Regulatory Specialist Role
Join Kardium as a Change Control Regulatory Affairs Specialist and enhance global regulatory compliance. Engage with multiple teams to assess product and process changes in a flexible, hybrid work environment.

In this critical role, you'll leverage your technical expertise to support Kardium's innovative medical device, the Globe® Pulsed Field System. Collaborate extensively with Engineering, Quality, and Clinical teams to ensure all changes meet stringent regulatory standards. Your analytical skills will be key in determining the regulatory reporting pathways.

Key Responsibilities:

• Represent Regulatory Affairs in the change control process

• Evaluate design changes and ensure compliance documentation

• Support global regulatory registrations and submissions

• Keep up with evolving international regulations

• Contribute to improving change control procedures

Requirements:

• Degree in Engineering, Science, or a related field

• Prior Regulatory Affairs experience in medical devices

• Skilled in assessing regulatory impacts of product changes

• Strong organizational and analytical skills

• Experience in software changes is advantageous

Play a vital role in regulatory assessments at Kardium today.
#J-18808-Ljbffr