Sr Manager - Product Surveillance (Biotech)
Main Objective: Ensure functional team engagement and Arthrex continuous improvement in the area of Product Surveillance / customer complaints. Drive a high degree of regulatory compliance in the areas of FDA Med Watch filing, Adverse Event filing, and Vigilance Reporting.
Essential Duties and Responsibilities:
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:
BS/BA Degree in engineering, business, regulatory compliance, or related areas.
At least 7 years senior level experience in handling complaints in an FDA /ISO regulated environment, and at least 3 years of leadership / management experience.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Knowledge of FDA, ISO, MDSAP and other international regulations regarding complaints and reportable events. Excellent proven interpersonal skills in dealing with all levels of professionals
Machine, Tools, and/or Equipment Skills:
Proficiency in the use of PC and programs, particularly Excel, Word, PowerPoint (or equivalents if changed by the Company). SAP, Documentum and / or Pilgrim experience desirable.
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.