Heather H. Email & Phone Number

Remote

PSURs and related technical documentation for medical device company through Eliassen Group.

Greater Chicago Area

Post Market Surveillance specialist involved in creation and maintenance of Post Market Surveillance reports, PSURs (Periodic Safety Update Reports), and PMS plans for class I-III medical devices, with a focus in orthopedics and trauma implants and instruments. Also involved in: PRER (PMS data for China NMPA), NPD, tracking and trending of complaints, ad-hoc reports. Audit backroom experience. Knowledge of SAP, Matrix, Pilgrim, Optiqs360 and Microsoft office suite. Current projects include software validation, R script outputs, and aligning PMS processes to the EU-MDR processes.

Greater Memphis Area

Post Market Surveillance analyst in charge of creation and maintenance of Post Market Surveillance files for medical devices at Smith & Nephew.

West Palm Beach, Florida Area

Completion of a remediation project on complaints spanning two years. SAP system usage.

Completed a retrospective review of a product as per FDA guidelines. Coding current complaints and assuring current guidelines are up to date. Completing and checking MDRs and remedial action exemption coding. Opening and closing complaints. Updating complaints with AE actions and information. Knowledge of 21 CFR Part 820 - Medical Device reporting. Completion of trending analysis.

Compiled patient chart data in relation to ongoing studies at the podiatry clinic. Investigated new methods of wound care treatment and supporting information for same. Represented the clinic at the Advocate Dimensions of Excellence conference in 2008.