Sr. Specialist, Regulatory Affairs

The Senior Regulatory Affairs Specialist will be responsible for the development of submissions for domestic and international clearances; as well as the support of daily activities related to new product development, change control, and regulatory product submissions.

Essential Duties and Responsibilities

• Collaborates as a core team member on new product development teams. Independently determines and documents appropriate regulatory strategy for proposed new products. Supports design control activities. Provides regulatory input to project timeline planning.
• Prepares regulatory submissions including 510(k) premarket notifications for US FDA
• Prepares regulatory submissions including technical files/design dossiers for registration of products in MDSAP countries and interfaces as needed with Notified Bodies regarding significant changes to products.
• Responsible for internal process improvements, data/metric evaluation,...