Vice President, Regulatory Affairs and Quality Assurance

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Vice President of Regulatory Affairs and Quality Assurance to work alongside our Product Development teams, providing regulatory compliance guidance, and facilitating the strategic registration of new and exciting products, globally. The successful candidate will work with Product Management, Engineering, Manufacturing, and Quality Assurance teams across all Arthrex sites to ensure Arthrex meets the highest standards of product safety and efficacy. Excellent interpersonal, presentation and leadership skills along with fifteen plus years or more of related experience and a bachelor’s degree are essential for this position.  Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Main Objective:

Directs, plans, develops, and coordinates all planning and implementation of practices, policies, programs, procedures, and personnel activities of an organization's quality and regulatory efforts.

Essential Duties and Responsibilities:

• Serving as the Quality Management System (QMS) representative for Arthrex, Inc., globally.
• Serving as the Regulatory Affairs representative for Arthrex, Inc., globally.
• Developing, implementing, and maintaining necessary Quality Systems to ensure compliance with all requisite regulatory agencies, including but not limited to FDA, ISO, foreign government regulations, etc.
• Managing and insuring proper filing of all required compliance documents, submissions, registrations, etc., globally.
• Directing and managing all internal audits, including tracking and follow-up on corrective and preventative actions.
• Directing and managing all high-level product surveillance activities.
• Developing, implementing, and maintaining necessary training programs to insure effective execution of QMS policies, procedures, and work instructions, and compliance with regulatory agency requirements.
• Maintaining current knowledge of FDA, ISO, and other global regulatory requirements, and keeping organization management apprised of the changing domestic and global regulatory landscape.
• Developing and managing departmental roadmaps, strategic plans, tactics, and budgets.
• Developing organization structure and skill levels to achieve organizational goals.
• Up to 15% travel.

Incidental Duties:

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 physical or life science.
• 15+ years in medical device organizations at a senior managerial level.
• Must have hands-on experience in developing, implementing, and sustaining comprehensive Quality Systems as required by FDA and ISO. Must have direct experience with FDA, ISO, and MDSAP inspections, including interaction, follow-through documentation, and product submissions.
• Must have product surveillance experience, including the initiation, execution, and resolution of product recalls and field alerts.
• Must have 10 years’ experience leading and managing a team. 
• Regulatory Affairs Certification preferred.

Knowledge and Skill Requirements/Specialized Courses and/or Training:

• Knowledge of FDA regulations, ISO 9001 standards, Quality Standard regulations. Strong interpersonal and communication skills.

Machine, Tools, and/or Equipment Skills:

Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), and SAP or equivalent business management software.

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.