Product Complaint Analyst Medical Device Reporting
Describe the primary goals, objectives or functions or outputs of this position.
Individual will work in global quality organization processing clinical and/or postmarket, medical device and combination product reports for complaints and communicating with global health authorities regarding inquiries.
Interface with internal and external customers such as physicians, nurses, pharmacists, hospital personnel, risk managers, purchasing agents, sales representatives, general public, manufacturing sites, technical support, commercial organization and PV regarding product complaints.
Responsible for product complaint documentation, investigations and identification of reportable adverse events and potential reportable events.
Responsibilities will include creation and submission of regulatory reports and third party interface.
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
Review global medical device and combination product complaints for the identification of reportable events in the local countries and for any reciprocal reporting requirements.
Responsible for the submission of US MedWatch reports and ensuring ex-US reportable events are reviewed prior to submission and submitted within the required timeframes.
Complaint documentation meets Good Documentation Practices. This requires good analytical skills, technical writing and good documentation. Responsible to ensure complaint files meet global regulatory requirements.
Responsible for on time reporting of Medical Device Reports (MDR) and Medical Device Incident Reports (MDIR) globally.
Run daily/weekly reports to track progress of reporting activities and to review new incoming information for any changes to reportability of a compliant.
Interface with Third Party Manufacturers, health care professionals, general public, internal customers,functional areas and regulatory agencies.
Potential oversight of management of a project team or participation on a project team involving process improvements, new product launches, issue resolutions, etc.
Potential Responsibility of a specific section of the complaint process and employees activities involved with that processing step.
List required and preferred qualifications (up to 10). Include education, skills and experience.
Knowledge of FDA Quality Systems, pre and post market product compliant handling and Medical Device Reporting regulations (21 CFR 803, 820) is preferred.
Comprehensive knowledge and application of computer system software including Excel, Word, and complaint management systems.
Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products.
Ability to prioritize workflow to ensure compliance with regulations and standard operating procedures.
Solid written/verbal communication and organizational skills.
Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.
Experience in nursing (MLT, LPN, RN), medical technology, biomed or other technical area.
Experience in a cGMP related industry or in a clinical setting (preferred)