Live and work in paradise!
We have an awesome, high visibility leadership opportunity for a dynamic Product Surveillance / Complaints Manager at the Arthrex corporate headquarters in Naples Florida. We are seeking a transformational leader that has a passion for continuous improvement and world class performance. If you have a bachelor’s degree (Engineering preferred), 3 years or more of proven complaint handling excellence in a Medical Device setting, and at least 2 years of team leadership distinction, apply now and experience life on Florida’s paradise coast!
Ensure compliance in the areas of complaints, consisting of but not limited to; FDA Med Watch filing, CMDCAS Adverse Event filing, MDD Vigilance Reporting.
Essential Duties and Responsibilities:
- Supervises and directs the efforts of the Complaints Department
- Reviews and approves complaints and complaint closure letters
- Responsible for the coordination of worldwide complaint data into appropriate management reports, analyzing trend data associated with complaints, drawing appropriate conclusions to trend data and presenting such data in a meaningful, usable format to management
- Responsible for interfacing with customers, distributors and doctors regarding complaint issues
- Participate in Management Review Meetings to disseminate complaint data
- Responsible for assuring the integrity and completeness of Complaint Files
- Responsible for staffing, positioning, hiring and disciplinary action (as necessary) the Complaints Department
- Responsible for maintaining procedures and practices related to complaint handling to assure compliance with ISO and FDA regulations
- Responsible for assuring timely review and closure of complaints
- Responsible for assuring complaints personnel are properly trained in all procedures and SOPs
- Responsible for maintaining efficient work flow, work assignments and throughput
- Responsible for participating in FDA and ISO audits, as well as other 3rd party inquiries as required.
Education and Experience:
- Bachelor’s degree required in engineering (preferred), business, regulatory, compliance or related areas.
- 3 years senior level experience in handling complaints in an FDA /ISO regulated environment.
- 2 years of management experience.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Knowledge of FDA and ISO 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 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.