Sr. Manager Regulatory Affairs Labeling
New Jersey, Bergen-Passaic
Our client, a Global Medical Device Manufacture has an immediate opening for a Sr. Manager Regulatory Affairs Labeling for a 6 Month + Contract. Our client offers results-driven people a place where they can make a difference every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.
Position Description (Principle Duties and Responsibilities)
The Senior Manager, Regulatory Affairs Labeling is responsible for leading and managing a group of Regulatory and/or Quality professionals (non-direct reports) to ensure regulatory compliance within and across our client. This position will be responsible for driving implementation of selected labeling regulatory requirements within Design Divisions, Manufacturing sites and International Divisions from a company-wide perspective.
Specific responsibilities include, but are not limited to the following:
Lead the development and implementation of selected regulatory labeling processes at a company-wide level for Regulatory Affairs, collaborating with other program, track or workstream leads.
Develop and support training for regulatory compliance and associated system implementations across programs and sites.
Manage the development, implementation and improvements/maintenance for any assigned company-wide eSystem ensuring linkages with other processes are compliant, effective and efficient.
Serve as business Owner of assigned eSystems to the IT team to develop system needs and design inputs to meet regulatory and user requirements for the Electronic Instructions for Use interface.
Serve as primary Regulatory contact within our clients specific division determining impact of any FDA or other regulatory agency changes on the system and process and leading the communication/training/awareness of those changes across the organization for both the business and IT.
Collaborate with other Global Process Owners (GPO) to implement and sustain regulatory compliance within respective impacted processes.
Partner with Design/International Divisions and GQO groups to support site level implementation and continued compliance.
Build team cohesiveness by leading, influencing, and motivating team members and ensure effective implementation of new/revised quality systems and procedures
Support working groups within industry organizations when assigned. Assure communication of accurate and timely information to internal stakeholders.
Participate in continuous (breakthrough) improvement activity and process re-engineering projects in support of development of regulatory related improvements. Conduct and support benchmarking activities when applicable.
Interface with industry professionals to identify best practices.
Bachelor s degree required and MBA highly desired.