Associate MDR Vigilance Specialist

Responsibilities:

• Supports intake evaluation, processing, and communications and investigations on complaints and adverse events according to procedures and government regulations.
• Provides administrative expertise in receipt, processing and reporting of product defect complaints, serving as primary contact.
• Ensures complete and accurate records and reporting of Medical Device Reports or adverse events as required by regulatory agencies. 
• Addresses and expedites product complaints under the company's complaint policy and procedures and ensures compliance with government regulations.
• Provides technical expertise to optimize complaint processing systems.
• Maintains and monitors systems to ensure that all product complaint investigations received are appropriately investigated and concluded per the company's complaint handling procedure
• Supports projects to develop or enhance programs and processes to meet regulatory reporting requirements.

Requirements:

• Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Minimum of Bachelor’s degree with a preference to science, health care or engineering degree and 0-2 years of relevant experience.
• Must have the experience working with Microsoft Office programs (Outlook, Word and Excel). Must be able to read and type the English language proficiently. 
• Work style will be full time, first shift. Will be required to be on site 2-3 days per week with the exception of time-off.  
• To be successful in this role, the candidate will need to be a self-starter, self-motivating, detail-oriented, able to work at a computer/desk setting, proficient in the English language, able to type proficiently, and skilled at technical writing and able to fluctuate between multiple activities/tasks.  
• Additionally, some experience working in data bases will be beneficial to this candidate’s success.  
• Some knowledge of good documentation practices (GDP), good manufacturing practices (GMP) and quality systems in a regulated environment would also be beneficial.