Medical Device Reporting Specialist

Complaint investigation and reporting, including phone calls to company representatives, hospitals, physician’s offices, and competitors. Consults with subject matter experts to make sound and accurate regulatory reporting decisions based on regulatory guidelines. Correspondence of returned medical devices with manufacturer. Facilitating correspondence between the manufacturer and field representatives, the FDA and other organizations Processing evaluation results of complaints supplied by the manufacturer and entering the data into our complaint system. Preparing for internal and external audits. Prepare and submit all MedWatch reports, both initial and follow-up reports to the FDA in compliance with regulations, guidelines and the required timeframe. Evaluate explanted (biohazard) medical devices and paperwork to make complaint determinations. Updating department work instructions as needed, including proof reading and following the approval process until completion.

According to JobzMall, the average salary range for a Medical Device Reporting Specialist in Bldg C, 6024 Jean Rd, Lake Oswego, OR 97035, USA is between $39,500 and $69,400 per year. This range is based on salaries submitted to JobzMall by employers and employees in the area.

BIOTRONIK is a leader in cardio- and endovascular medical technology (pacemakers, implantable defibrillators, stents and remote patient management).