Regulatory Specialist Sr

Title: Senior Regulatory Affairs Specialist

• Provide regulatory support for Rebranding, Labeling and Packaging Update Projects for Heart Failure products
• Initiate, Review and Approve Change Orders related to various assigned Projects
• Communicate with International Regulatory Affairs affiliates and provide adequate information for initiating Regulatory Assessments
• Navigate and provide regulatory input to the develop approaches for Packaging and labeling updates
• Supports a collaborative environment to align with other cross functional individuals
• Active follow-up on the progression of day-to-day documentation activities required to successfully and timely complete the deliverables
• Supports the Technical Publications team to update Labels and IFUs and align with the requirements
• Supports the Packaging team to update Packaging design and drawings and align with the requirements
• Stay abreast of all pertinent regulatory affairs/ quality system issues specific to projects
• Applies skill set to navigate through the various regulatory operations activities as necessary

Mandatory Requirements

• Medical Device Regulatory Affairs (2+ years)
• B.S. in Engineering or Life sciences or an alternative Bachelor's degree program with experience in Engineering or Life Sciences
• A Masters degree in Regulatory Affairs can substitute for years of experience
• Cross functional understanding of Design Control, Packaging, Labeling, Risk Management, Clinical Affairs as required to support RA submissions