Senior Regulatory Specialist

The Senior Regulatory Specialist provides services to fulfill the regulatory requirements necessary to achieve global regulatory approvals / clearances and maintain overall regulatory compliance for the company. 

Duties and Responsibilities (Key Deliverables): 

1. Preparing and maintaining FDA pre-market submissions, Canadian device license applications and international product registrations for medical devices.
2. Preparing and submitting MDD Class III Design Dossiers for review by the Notified Body.
3. Providing regulatory strategy and support for new product development projects:

• Design team participation
• Design Control requirements
• CE marking requirements / Technical File (STED) / Design Dossier compilation
• Pre-market regulatory submissions
• Canadian device license applications
• International product registrations – STED File organization
• Product labeling review and approval

4. Independently manage medium to large scale regulatory project initiatives
5. Provide input into corporate regulatory strategies
6. Ensuring that company procedures, processes and documentation meet the required guidelines for maintaining FDA compliance and ISO/EC/CMDR certification, including the application of Design Control and Risk Management processes.
7. Participate as needed in the complaint handling, corrective and preventive action and internal quality audit processes.
8. Knowing and applying Exactech’s Quality Management System and any appropriate federal and international standards.
9. Providing knowledge and support to the company’s different business units to enable operation within company and regulatory guidelines.
10. Assisting and supporting other employees, teams, and sales personnel as necessary.
11. Practicing Exactech’s Values.

Job Requirements: