Regulatory Affairs Specialist

Develop regulatory submissions for domestic and international spinal product clearances. Support our spinal product design teams concerning change control and spinal product regulatory submissions. Duties include:

1. Provide expertise on domestic and OUS regulatory strategies for products, including spinal devices, medical software (SaMD), medical devices containing software, radiation emitting devices, and cybersecurity;
2. Support design control activities for spinal devices, medical software (SaMD), medical devices containing software, and radiation emitting devices;
3. Apply IEC 62304 requirements during the development and improvement of the software lifecycle process for domestic and OUS submissions;
4. Prepare regulatory submissions, including 510(k) premarket notifications for the FDA;
5. Maintain FDA establishment listings and registration;
6. Prepare regulatory submissions, including technical files and design dossiers...

Reports to: Manager of Regulatory Affairs

Responsibilities:

• Assist the Manager of Regulatory Affairs during cGMP, Environmental, and Regulatory audits.
• With the assistance of Head of R&D (or designee), create and collate product master files (dossiers), drug master files (DMF).
• Generate and Review of Product CoCs, CoAs, CoMs, BSE documents, CMR documents, RM Certificate of Analysis, Safety Data Sheet, technical documents, RM composition breakdown, as may be required for local and international submissions.
• Generate Raw Material Regulatory statement: Origin Statement, Cruelty Free statement, Heavy metal statement, Impurity statement, Food allergen statement, Fragrance allergen statement, Nitrosamine-free Statement.
• Review Customer “No-No List, Special Store Prohibited List, Prop 65, REACH Compliant Statements, Global and regional Compliance statements, EU/China-compliant statement, etc....

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.
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