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):
Preparing and maintaining FDA pre-market submissions, Canadian device license applications and international product registrations for medical devices.
Preparing and submitting MDD Class III Design Dossiers for review by the Notified Body.
Providing regulatory strategy and support for new product development projects:
International product registrations – STED File organization
Product labeling review and approval
Independently manage medium to large scale regulatory project initiatives
Provide input into corporate regulatory strategies
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.
Participate as needed in the complaint handling, corrective and preventive action and internal quality audit processes.
Knowing and applying Exactech’s Quality Management System and any appropriate federal and international standards.
Providing knowledge and support to the company’s different business units to enable operation within company and regulatory guidelines.
Assisting and supporting other employees, teams, and sales personnel as necessary.
Practicing Exactech’s Values.
Bachelor’s Degree from an accredited institution required.
· Minimum 5 years experience in FDA/ISO medical devices quality management system standards required
· 5 years experience in FDA pre-market submissions (510(k) and/or PMA) and international product registrations required
· Technical writing skills required
· Experience in Design Controls
Functional/Technical Knowledge, Skills and Abilities Required:
· Working knowledge of windows based office productivity tools including word processor and spreadsheet
Internal Number: SENIO01615
About Exactech, Inc.
Based in Gainesville, Fla., Exactech innovates, manufactures and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech is one of the fastest growing orthopedic implant manufacturer in the industry and markets its products in the United States and in more than 25 countries in Europe, Asia, Australia and Latin America. Exactech's tremendous culture stems from our core values and our belief in giving our customers and employees and exceptional work experience! Exactech is an equal opportunity employer.