Manages the daily operations of the Quality Assurance and Regulatory Affairs department and assures regulatory submission compliance for California Operations. Maintains understanding and compliance requirements of regulatory affairs affecting company operations and products. Generates and manages submission documents for new products or changes to existing regulatory submissions. Responsible for ensuring that the Quality System is effectively established and maintained.
Essential Duties and Responsibilities:
1. Has overall responsibility for the Quality Assurance Department, including Supplier QA, Documentation Control, Quality Engineering, and Customer Complaints.
2. Responsible for maintaining a Quality System that is in compliance with worldwide medical device regulations, including FDA Quality System Regulations and European Medical Device Directives.
3. Serves as the Quality System Management representative for ISO 9000 and ISO 13485.
4. Participates in the design control process to establish quality plans and Design History Files.
5. Assisits in the maintainance of the Total Quality Management System, including electronic document control database, between Arthrex Inc., AMI, ACT and ACI.
6. Writes, submits, and coordinates new product 510 (k) notifications, CE Mark Technical Files/Dossiers, Canadian Submissions, Investigational Device Exemptions (IDEs) and Premarket Approval Applications.
7. Maintains FDA registration and listing files - including interim and annual reports.
8. Participates in Quality System Audits conducted by FDA and CE Notified Body.
9. Assures International regulatory compliance, submissions, and approvals
10. Acts as a corporate liaison between all regulatory city, county, state, and federal agencies concerning medical devices.
11. Participates in product safety alert/recall policy development and coordinates recalls.
12. Participates and leads as required IDE/PMA projects
13. Review and approve labeling, literature, etc.
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
Education and Experience:
Bachelor's degree required preferably in a Science or Engineering discipline.
Training in technical aspects of regulatory affairs.
7 years direct experience in Regulatory Affairs/ Quality Assurance in a Medical Device Company required.
3 years management experience required.
Experience working with International notified bodies (CE Mark) and with the FDA preferred.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
In-depth knowledge of quality assurance techniques, practices, ISO and Regulatory (FDA) compliance
Ability to manage diverse department, and develop personnel in accordance with company objectives.
High degree of understanding of regulatory requirements - how they operate, how to obtain updated information and where to obtain interpretations of them.
RAC Certification a plus
Machine, Tools, and/or Equipment Skills:
PC, database, precision test and measurement equipment.
Arthrex’s corporate headquarters is located in Naples, Florida where visitors will find a vibrant atmosphere of rapid product innovation, medical research and surgeon collaboration. The sprawling campus houses corporate and manufacturing operations, as well as Arthrex’s premier Medical Education Center, which serves as an education destination for surgeons from around the world to learn about new products and techniques through hands-on surgical skills training programs.
Incorporated since 1981, Arthrex has been committed to just one thing: helping surgeons treat their patients better. Arthrex has pioneered the field of arthroscopy and developed more than 6,000 innovative products and surgical procedures to advance minimally invasive orthopedics worldwide.
Arthrex continues to experience unprecedented growth and demand for our products throughout the world; however, we remain a privately-held company with a family business culture that is committed to delivering uncompromising quality to the healthcare professionals who use our products, and ultimately, the millions of patients whose lives we impact.
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