Position Summary:
Supports quality and operational activities, including projects to successfully meet department and corporate goals. Key contributor in support and collaboration for the following:
State, Federal, and international distribution and manufacturing licensing
FDA establishment licensing and device listings
Global site registrations
Audits State, FDA, Notified Body, global regulatory bodies
Lead compliance-related projects
Additional responsibilities as assigned

Works closely with multi-site global Quality, Commercial, Legal, Planning, Supply Chain, Logistics and Operations teams to ensure compliance with numerous state, federal and global regulatory agencies.

Functional Description:
Work is primarily achieved by individual along with others, or through project teams, utilizing technical or subject-matter expertise to achieve results
Emphasizes in-depth technical / subject-matter knowledge, project management and influence skills
Is expected to communicate effectively both vertically and horizontally within the organization, with suppliers and with customers.
Is expected to have strong lateral leadership skills, and be able to influence decisions within all project teams they are part of
Essential Duties and Responsibilities:
Researching and completion of state, Federal and international manufacturing and distribution licensing laws, rules, and statutes for applicability
Ability to lead complex projects through advanced project management skills
Support internal and external audit activities as assigned (fulfill audit requests, review records for accuracy, scribe, etc.)
Must have the ability to read and understand legal terminology, or the interest and capacity to learn
Must have a strong drive to develop partnerships throughout the organization to advance the departments influence and impact.
Must have innovative resolution skills in pursuit of continuous improvement efforts
Must be able to assess risk and deploy action appropriately, including the escalation of matters which warrant.
Must be able to independently manage their time and prioritize competing priorities to meet established deadlines
This job description reflects management's assignment of essential functions; it does not prescribe or restrict the tasks that may be assigned.