The Regulatory Affairs Manager manages the day-to-day operations of the Regulatory Affairs Team within an assigned product area or regional area to help ensure the process produces effective regulatory submissions and timely regulatory approvals.
• Manage workload and workflow of assigned regulatory area
• Communicate directly with RA leadership on proposed improvements
• Manage submissions generated for their assigned regulatory area
• Actively pursue ways in which to improve the function of the Regulatory Affairs Department
• Communicate directly with regulatory agencies and distributors
• Manage the progress of RA team members on assigned tasks, and remove roadblocks
• Helps refine and implement Regulatory practices/procedures
• Provide direction and logistical support to the RA team members to complete assigned tasks
• Effectively communicate with and coordinate resources
• Manage accountability within the team to meet established time lines
• Accountable for managing and reporting metrics to the RA team
• Responsible for performance and wage reviews for team members
• Foster and maintain a workplace culture respectful and supportive of individual differences
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization
• Must strictly adhere to safety requirements
• Maintain regular and punctual attendance
• Must maintain company quality and quantity standards
• Must have effective oral and written communication skills
• Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision
• Ability to remain calm and receptive in fast paced situations
• Implement policies, programs and directives of senior management
• Interview, select and approve all training for employees
• Make recommendations for staff and equipment and have significant input into personnel matters.
Minimum Work Experience/Educational Requirements
• Minimum 4 years Regulatory experience in the medical device field and/or 5 years Regulatory experience with Cook Medical.
• Bachelor’s degree in a life science (preferably biology or life science) or other related field; or experience of such kind and amount as to provide a comparable background
• Completion of RAC preferred
• Proven project leadership skills.
• Demonstrated ability to provide consistent leadership in a team setting
• Demonstrated ability to manage conflict, communication & resources
across multiple projects
Physical Requirements/Work Environment
• Requires occasional early morning or evening teleconferences
• Must be willing and able to travel as needed
• Works under general office environmental conditions
• Sites for extended periods, utilizes close visual acuity for working with
• Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA.