Summary: The Regulatory Affairs Specialist is responsible to identify potentially reportable incidents and product problems upon receipt of complaints. The individual will report MDR/AE eligible events to the FDA within the regulatory requirements and identify, and initiate product event investigations to satisfy MDR/AE requirements.
Maintain complete complaint files and databases for all customer complaints, according to FDA, international regulatory and compliance requirements related to the complaint system process
Review all received complaints for regulatory reporting requirements (MDR/AE) within timeframes mandated by FDA and potential impact to patient safety and business operations
Initiate and complete MedWatch reports for timely submission to the FDA
Investigate specific events by contacting internal resources, Invacare field personnel and/or distributors/customers as appropriate
Ensure identification of root cause analysis and to define the documented and measured actions to be taken in order to resolve the root cause of the issue
Assist to resolve all complaint management related CAPAs
Maintain awareness of new products, government regulations and requirements
Develop and maintain integrated system post market safety reports for all Invacare products
Provide input on methods to maintain MDR/AE compliance continuously
Constantly update and share knowledge on changing regulatory policies with the department
Complete all required training applicable to assigned position.
Additional duties as requested or required.
Bachelors degree in Engineering, Science, Healthcare, Regulatory Affairs or equivalent degree (such as a licensed healthcare practitioner), or equivalent regulatory experience. Masters degree preferred.
Minimum one (1) to three (3) years of experience in a medical device company within regulatory affairs or medical documentation and reporting
Experience in the medical field and or understanding of medical terminology and language. Clinical experience preferred
Knowledge of 21 CFR 803/806/820, ISO 135485 and MEDDEV 2.12-1
Professional certification by AORN, AACN, ENA or other nationally recognized body preferred
Strong communication, analytical, organizational and management skills
Ability to work hours and shifts between 8 a.m. and 8 p.m.
Proficiency with MS Office, MS Project, Visio, electronic document management