Vigilance Writer

• The  Global Product Monitoring Vigilance Report Writer  develops, establishes, and maintains quality assurance methodologies, systems, and medical device industry best practices which meet customer, regulatory, and client requirements; serves as a post-market vigilance (reportable event) and surveillance subject matter expert and representative to improve awareness, visibility, and communication on quality/compliance initiatives to support departmental, divisional, and corporate quality goals and priorities; works on problems of diverse scope where analysis of data requires evaluation of identifiable factors; demonstrates good judgment in selecting methods and techniques for obtaining solutions; and networks with senior internal and/or external personnel in own area of expertise.     

Responsibilities:

• Responsible for the assessment, follow-up, coding, and vigilance activities for complaints globally.
• Author, peer review, and approve vigilance reports to ensure on time submissions to the  appropriate regulatory  authorities.  
• Support management in day-to-day operations in a fast-paced work environment; Support proper coding of complaints and reportable events.  
• Collaborate with engineering, complaint investigation laboratory, medical and other internal staff as applicable to review events, coding, and investigation results to support regulatory reporting compliance occurs per procedures, standards, and regulations.  
• Contribute to departmental non-conformances escalated into CAPA System
• Serve as a subject matter expert for post-market and complaint handling regulatory questions and inquiries.
• Support internal and external audits and inspections.
• Assist  with special projects, as assigned, with minimal supervision.  
• Perform other duties as  required.

Minimum Requirements:

• Bachelor's degree or  appropriate combination  of relevant education and experience.
• Demonstrated experience in medical device complaint triage and vigilance reporting or clinical experience in diabetes disease management or diabetes device support.  

Preferred Skills and Competencies:

• Strong  proficiency  in common computer applications such as Microsoft Office (Excel, Word, Outlook) and complaint database applications.
• Effective verbal and written communication skills.
• Ability to generate, verify, and  maintain   accurate  records.
• Must have analytical skills, be detail oriented, and have good interpersonal skills.
• Demonstrated ability to influence without authority.
• Ability to organize, judge priorities, and escalate when applicable.  
• Strong emphasis and understanding of a formalized medical  device  Quality Management System.  
• Direct experience of writing and filing global vigilance reports within the medical device industry.  
• Working knowledge/experience with global, multi-country vigilance reporting requirements for medical devices and  demonstrated  knowledge of country-specific differences and requirements.  
• Experience in dealing directly with regulatory bodies is highly desired.  
• BSN with diabetes experience, Registered or Licensed Dietician or Diabetic Educator, preferred.

Travel and Physical Requirements: 

• General office environment – may sit for  long periods  of time.
• This position requires extensive computer use.
• May require up to 10% travel