Hybrid Associate II, Regulatory Affairs

at ICU Medical

• Job title: Associate II, Regulatory Affairs
• Job type: Full Time
• Experience level: Junior, Mid level
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Southington, United States

About the role

• Provides regulatory support for global device registration at ICU Medical. Assisting with global strategies and compliance for device product registration.

Responsibilities

• Provides regulatory support and guidance associated with global and US registration of device products, including analysis of the requirements and tracking of deliverables.
• With oversight, supports execution of global regulatory strategies and assists in creation and maintenance of global registration dossiers.
• Assures full regulatory compliance of all documentation for submissions and change management.
• Drives projects forward and executes agreed upon strategies and plans with oversight. Maintains awareness of applicable regulations.
• Plans and organizes registration packages for device products. Prepares registration packages in line with local regulatory requirements and guidelines.
• With oversight, understand and respond to regulatory agency correspondence.
• Evaluates manufacturing and labeling changes for regulatory impact. Accurately describes these changes for ease of regulatory agency review.
• Work with region and country RA counterparts to evaluate changes for regulatory impact and to ensure compliance with applicable regulations. Accurately describes these changes for ease of regulatory agency review.
• Represents Global Regulatory Affairs at research and development meetings and presents agreed upon regulatory positions. May serve as a lead regulatory representative to an assigned product or project team.

Requirements

• Bachelor’s Degree required, preferably in pharmacy, biology, chemistry, pharmacology, engineering or related subject.
• RAC Certification preferred
• A minimum of two years of experience in Medical Products Industry in Regulatory Affairs.
• Able to assess scientific arguments and apply analytical and logical reasonings.
• Ability to effectively prioritize workload and multitask with minimal supervision.
• Good interpersonal skills.
• Good oral and written communications skills.
• Demonstrated project management skills.
• Demonstrated critical thinking, contingency planning and negotiating skills.
• Understanding of regulatory and business needs with ability to engage cross functional team members.
• Must be at least 18 years of age.

Benefits

• This is largely a sedentary role.
• This job routinely uses standard office equipment.
• Typically requires travel less than 5% of the time.