Job: Medical Device Reporting (MDR) Analyst

We are currently seeking a MDR Analyst. This is a great opportunity for the right candidate with a biotechnical background.

Job Description:

Will work as part of the Regulatory Affairs (RA) department with responsibility for evaluating complaints for MDR reportability, MDR filings and FDA updates as necessary. Follow up with internal and external sources as necessary to ensure complete documentation of regulatory-related complaint information.

Tasks and Responsibilities:

•Carry out duties in compliance with established business policies and procedures.
•Performs other needed functions as required.
•Daily review of work list generated in complaint database for complaints pending Regulatory Reporting Decision
•Preparation of required reports to be submitted to appropriate regulatory agency, including MedWatch (FDA), Vigilance/Incidence Reports (EU) and Mandatory Problem Reports (MPR) (Canada)
•Maintenance of individual spreadsheet/log to track status of MDR, Vigilance or MPR that may require follow-up reports

Bachelor’s degree (BS/BA) in life sciences or engineering (or equivalent combination education and/or work experience).

Preferred experiential background:

•Basic knowledge of quality systems in a biotechnical/medical device environment.
•Ability to work cohesively with multi-disciplinary working groups.
•Preference given to those with 1+ year regulatory experience in a medical device or IVD manufacturing environment.
•Good organization, interpersonal and judgment skills.
•Strong written, verbal communication skills.
•Proficient with Microsoft Office and comfortable working with computers and learning new software programs.
•Attention to detail is a must.