Associate Mdr/Vigilance Specialist

Associate MDR/Vigilance Specialist (12 month contract // Lafayette, CO):

Candidate will be required to work hybrid, on site at least 2 days per week

HM's Top Needs:

1. Computer skills – Microsoft Office – Outlook, Word and Excel. Including ability to read and type the English language proficiently. Experience working in a database and / or One Note preferred, but not required.
2. Attention to detail
3. Adaptable – able to fluctuate between multiple activities/tasks.

Description:

While the specific roles of this individual may change once on the team, the current plan is to have this person focus on complaints that come from on-going Litigation pertaining to Mesh products. Training will be provided on the documents that are received. However, the candidate will need to be comfortable reading through legal documents and understand some medical terminology.

Education Required: Bachelors Degree, with a preference to science, health care or engineering degree

Years’ Experience Required: 0-2 yrs

Duties:

• Provides technical expertise to optimize complaint processing systems.
• Addresses and expedites product complaints under the company's complaint policy and procedures and ensures compliance with government regulations.
• 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.
• 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.
• Supports intake evaluation, processing, and communications and investigations on complaints and adverse events according to procedures and government regulations.
• Review of legal documents, including post market surveillance documentation related to on-going litigation.

Required Knowledge and Experience:

• Minimum of Bachelor’s degree with a preference to science, health care or engineering degree and 0-2 years of relevant experience.

Preferred Qualifications:

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. Additionally, some knowledge of medical terminology and 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.