Sr. Regulatory Affairs Specialist
New Jersey, Bergen-Passaic
Our client, a Global Medical Device Manufacture has an immediate opening for a Sr. Regulatory Affairs Specialist for a 12 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)
Responsibilities include formulating process remediation and implementation strategies; preparing written assessments and presenting recommendations to executive level clients. Able to facilitate organizational change through effective communication, building consensus and creating complete and coordinated implementation plans. Requires a high level of subject matter expertise in the specified area. Demonstrated analytical and project management experience. Strong business savvy and negotiation skills. Extensive experience in business analysis and program implementation.
Provides deep subject matter expertise in the requested field to achieve business objectives such as operational efficiency, regulatory compliance, or improving competitive position.
Analyzes problems and recommends strategies to client to achieve business objectives.
Leads cross-function teams in developing or reengineering processes using requirements gathered from clients.
BA degree required, preference is Masters level education.
10 years experience in Regulatory affairs in Medical devices
Strong RAQA general knowledge including knowledge of Global regulations
Project Management Experience
Experience of working cross functionally and leading teams
Strong communication and team working skills
Attention to detail