Regulatory Affairs Specialist

　　Long Term Contract Opportunity

　　Pharmaceutical Company

　　Description:

　　Responsible for implementing and maintaining the effectiveness of the quality system.

　　Supports manufacturing/operations day to day activities for change control.

　　Provides consultation/advice to regulatory specialist for change control and product development.

　　Provides regulatory direction/interpretation on team activities.

　　Interprets and applies regulatory understanding to support of products and teams.

　　Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide.

　　Handles regulatory activities involved in documentation labeling field support.

　　Applies regulatory and technical knowledge to a wide variety of complex work assignments.

　　Maintains and ensures compliance to the appropriate quality system for the specific medical devices designed or manufactured that the individual supports.

　　Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.

　　Qualifications Needed:

　　5 years of regulatory experience and/or 2 years relevant industrial experience typically with a quality product-development/support or scientific affairs function

　　Knowledge of regulations and standards affecting IVDs and/or biologics

　　Education: BS preferred in a technical discipline like biology chemistry microbiology immunology medical technology etc.

　　Diversity, Equity & Inclusion

　　At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

　　Hiring diverse talent

　　Maintaining an inclusive environment through persistent self-reflection

　　Building a culture of care, engagement, and recognition with clear outcomes

　　Ensuring growth opportunities for our people

　　Actalent is an equal opportunity employer.

　　About Actalent

　　Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.