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 team members' workload and workflow of assigned regulatory area
• Communicate directly with Regulatory Affairs 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 Regulatory Affairs team members on assigned tasks and remove roadblocks
• Help refine and implement Regulatory practices/procedures
• Provide direction and logistical support to the Regulatory Affairs 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 Regulatory Affairs team
• Responsible for performance and wage reviews for team members
• Foster and maintain a workplace culture respectful and supportive of individual differences
• Minimum 5 years Regulatory experience in the medical device field
• Manager experience preferred
• Bachelor’s degree in a life science or other applicable field
• Works on-site up to 2-3 days per week (hybrid model)
• Can live up to 2 hours travel from office
• Must be willing and able to travel as needed
• Requires occasional early morning or evening teleconferences
• Sits for extended periods, utilizes close visual acuity for working with computers, etc.
Equal Opportunity Employer
Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to supply sponsorship for employment visa status (e.g. H-1B or TN status) for this employment position.