What are the responsibilities and job description for the Regulatory Strategy and Compliance Manager position at IntePros?
Key Responsibilities
- Drafts and submits regulatory documentation for Class II and III medical devices;
- Works closely with Product Development and Management teams to ensure compliance with FDA regulations;
- Develops and implements regulatory strategies to support product development and commercialization;
- Reviews and approves clinical study data for IDE and PMA reporting;
- Trains new staff on relevant regulatory processes;
- Reviews and approves document change orders for regulatory compliance;
- Maintains approved PMAs and prepares supplements and annual reports;
- Determines regulatory pathways for new and changed products;
- Reviews and approves regulatory pathway forms and supporting documentation.
