What you will do:
· Lead teams to support regulatory processes for market access of products
· Manage budget, if appropriate
· May lead the development of new systems and procedures
· Plans, conducts, and supervises assignments
· Review progress and evaluate results
· Support continuous improvement activities
· Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct report to meet or exceed these targets
· Recruit, select, and on-board top talent Develop talent within team to increase performance
· Actively address performance issues on team
· Maintain a high level of team engagement
· Participates in advocacy activities of a technical audit/nature
What you need:
Required:
· Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements
· Demonstrate technical knowledge of medical device, tissues, and/or drug product lines
· Demonstrated written, verbal, listening, communication, and team-building skills
· Demonstrated ability to collaborate effectively with and lead cross-functional teams
· Demonstrated ability to effectively prioritize and manage multiple project workloads
· Demonstrated experience with trending and analysis reporting
· Demonstrated leadership skills
· Demonstrated process improvement and management skills
· Experience with recruiting, people development
· Influence across the organization
· Ability to understand scientific and health concepts
Preferred:
· BS in a science, engineering or related degree. Advanced degree preferred
· Master's Degree or equivalent preferred. RAC preferred
· Minimum of 8 years’ experience; 3 years supervisory experience preferred
Travel Percentage: None