Regulatory Affairs Vice President
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 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 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™.
Directs, plans, develops, coordinates and implements all practices, policies, programs, procedures, and personnel activities of the organization's Global Regulatory Affairs Department.
Essential Duties and Responsibilities:
- Developing, implementing, and maintaining required Regulatory compliance with all requisite regulatory agencies, including, but not limited to, U.S. FDA, EU/ISO, Canadian, Asia-Pacific and Latin America regulations.
- Managing proper filing of all required compliance documents, submissions, registrations in accordance with global company business objectives.
- Maintaining current working knowledge of FDA and global regulatory requirements, and keeping organization Management apprised of new developments and potential impacts to the organization.
- Developing and managing departmental strategic plans, tactics, and budgets.
- Developing a global organizational structure with requisite skill levels to achieve global organizational goals and objectives.
- Ability to interact with Global Regulating Agencies (FDA, Notified Bodies, etc.) to secure product approvals and define Regulatory strategies.
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' experience in a global medical device manufacturing organization at a Senior Regulatory level OR a combination of 15 years of medical device and pharmaceuticals at a Senior Regulatory level.
- 10 years' experience leading and managing a team.
- Must have hands-on experience in developing and implementing comprehensive Regulatory Affairs processes, procedures and strategies, in accordance with FDA, EU/ISO, Canadian, Asia-Pacific and Latin American regulations.
- Regulatory Affairs Certification preferred.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
- Knowledge of relevant FDA, EU/ISO 13485, and global Regulatory System regulations.
- Strong interpersonal and communication skills.
- Bi-Lingual language skills is a plus.
Machine, Tools, and/or Equipment Skills:
Proficiency in the use of MS Office and SAP.
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.
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