Regulatory Specialist II

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.

Skills

regulatory affairs, medical device, regulatory submission, fda

Additional Skills & Qualifications:

• Bachelor's degree and 2+ years of experience

Please send your resume and 2-3 professional references to ~~~

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email ~~~ (~~~) for other accommodation options.