MAIN JOB RESPONSIBILITIES / COMPETENCIES
Post-Market Surveillance
1. Manage all aspects of complaint handling team activities to ensure that the process is compliant with applicable domestic and international regulations (i.e. U.S. Food and Drug Administration-FDA; European Economic Area Medical Device Directives; Canadian Medical Device Regulation; Japan Pharmaceuticals and Medical Devices Agency - PMDA) and other appropriate regulations and guidelines, as well as Company quality system requirements.
2. Ensure that Complaint Handling SOPs appropriately reflect these regulations and requirements and that complaint handling personnel are adequately trained in procedures relevant to their activities.
3. Act as company liaison with regulatory agencies including the FDA, Notified Body and other governmental agencies, in respect to communications related to complaints and audits.
4. Provide complaint data and analysis to the Post-Market Surveillance system as per procedures which includes but is not limited to:
a. maintenance, monitoring, trending of complaint data and presentation of the data for evaluation through management of the Device Safety Committee.
b. maintenance, monitoring, trending of complaint data and presentation of the data to be evaluated and utilized in the process of Risk Management and Clinical Evaluation.
c. initiation of corrective/preventive actions as needed.
5. Report status of complaint handling process and critical issues to Executive Management
6. Manage all aspects of current post-approval study (Post-Approval Patient Survey Study-PAS), including submission of interim reports, ensuring that the study is compliant with applicable FDA and (where applicable) international regulations, as well as Company quality system requirements.
7. Provide clinical data and analysis to the Post-Market Surveillance system as per procedures which includes but is not limited to:
a. maintenance, monitoring, trending of clinical studies data and presentation of the data to the Device Safety Committee for evaluation .
b. maintenance, monitoring, trending of clinical studies data and presentation of the data to be evaluated and utilized in the process of Risk Management and Clinical Evaluation.
8. Regularly report status of clinical studies to Executive Management
9. Provide support for medical affairs activities, as requested.
General
1. Other duties as assigned.
REQUIREMENTS
EDUCATION & TRAINING
• B.A./B.S. degree in scientific field.
EXPERIENCE
• Minimum 5 years' experience in an FDA-regulated environment, preferably with quality management experience. Experience with the review, statistical analysis, and presentation of scientific data is required.
SKILLS
• Strong statistical, analytical, and data-processing skills.
• Excellent written and oral communication, and technical writing and editing skills.
• Ability to manage and prioritize multiple projects and organize departmental resources to meet business objectives.
Pay range is $160K - $190K - Final compensation will depend on experience.
