Work Flexibility: Hybrid
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