The Regulatory Reporting Specialist is responsible for the timely submission of adverse events and responses to request for additional information from regulatory authorities and customers for medical devices. This position includes working with multidisciplinary and cross functional teams and conducting due diligence to ensure completion and closure of complaints files.
- Communicate event reporting and investigation results through regulatory reports and written communications.
- Evaluate complaints and determine if the submission of a Medical Device Report (MDR) or other Vigilance Report is required.
- Completes and submits regulatory reports within the time frames mandated by regulators.
- Review and evaluate complaints with new or additional information to determine reportability.
- Request additional information as needed for complete understanding of the event.
- Generate various ad hoc reports as requested for internal and external customers.
- Enter information related to the event into the complaint file.
- Review regulatory request for additional information and develop responses to various global regulatory authorities.
- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.
- Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
- Must strictly adhere to safety requirements.
- Maintain regular and punctual attendance.
- Must maintain company quality and quantity standards.
- Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with minimal supervision.
- Ability to remain calm and receptive in fast paced situations.
How to Apply
Apply Here: https://americas-cookmedical.icims.com/jobs/5756/regulatory-reporting-specialist/job