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 over 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 team plays a critical role in all phases of the device lifecycle, from design, development and device approval to post-market surveillance. Our team interprets and applies regulations to enable Applied Medical’s devices to make a meaningful, positive difference in more than 80 countries! We collaborate with Engineering and Clinical Development in the design and development process of our medical devices, which includes the application of risk management principles.
Our team is expected to apply creativity and critical thinking to market implementation and regulatory submission strategies. We also play a key role in the product configuration management process. In some markets, we manage the device approval process as the license holder, and in other markets, we manage the device approval process through distributors.
The combination of Applied Medical’s mission to meet our customers’ needs and our vertically integrated business model results in rapid product evolution. This means that our Regulatory Affairs team members operate in a fast-paced, dynamic and rewarding environment.
Applied Medical’s culture prioritizes team member development, so intentional and effective leadership is crucial to cultivating an environment in which team members’ needs are met. Being a manager in the Regulatory Affairs team means that you have a thorough understanding of Applied Medical’s Quality Management System (QMS) and are responsible for identifying and creating opportunities for our team members to mature and grow professionally. Management candidates are offered a curriculum of courses and workshops designed to develop leadership, communication and management skills and to solidify their understanding of Applied Medical’s culture and business model.
We kindly ask that you submit a cover letter explaining your career interests as a supplementary document to your résumé and application.
As Premarket Regulatory Affairs Manager, you will be responsible for being a self-starter and working in a collaborative environment to perform the duties listed below.
This position requires the following skills and attributes:
The following skills and attributes are preferred: