Applied Medical is a new generation medical device company with a proven business model and commitment to innovation that has fueled our rapid business growth and expansion. Applied Medical has been developing and manufacturing advanced surgical technologies for nearly 30 years, and has earned a strong reputation in healthcare. Our dedication to delivering the highest quality products and unique business positioning, provides our team members with the unique ability to contribute in a larger capacity than is possible in typical positions.
The Regulatory Affairs (RA) Analyst/Specialist will have an understanding of domestic and international Regulatory Affairs and provide support to Applied Medical's Engineering program from a Quality Management System perspective. This position is responsible for active participation in meetings, executing regulatory activities, and the review/approval of documentation associated with design controls, good manufacturing practices and medical device quality management. The role involves guiding internal teams on regulatory strategies to bring products to market as well as compliance with Applied's Quality System. The analyst and specialist roles are distinguished by level of relevant industry experience.
As an RA Analyst/Specialist, you will be responsible for performing the following activities:
This position requires the following skills and attributes:
The following skills and attributes are preferred: