Regulatory Affairs Specialist
Alphatec Spine
Carlsbad, california
Primary responsibilities include the development of submissions for domestic and international clearances. Additionally, will assist to support daily activities such as new product development, change control, and post market surveillance.
Essential Duties and Responsibilities
- Collaborates as a core team member on new product development teams. Determines and documents appropriate regulatory strategy for proposed new products. Supports design control activities.
- 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, maintenance of internal and external databases, and public-facing information. ...