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:
a. Design team participation
b. Design Control requirements
c. CE marking requirements / Technical File (STED) / Design Dossier compilation
d. Pre-market regulatory submissions
e. Canadian device license applications
f. International product registrations – STED File organization
g. 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.
Education: 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.
Bachelors or better.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)