Our mid-sized client is looking to add a Principal and Sr. Compliance Specialist to add to their growing team. The main responsibilities will be Field Corrective Action (FCA) and Recall Management for Medical Devices. Will be leading teams to develop field corrective action and recall plans. Oversee execution and reconciliation of field corrective actions and recalls. Working with cross-functional partners to determine root cause and population bounding as well as with Health Hazard Evaluations and Risk Assessment of patient safety. Develop and prepare correspondence to external government agencies and external customers. Prepare requests to regulatory authorities for field action termination and prepares closure reports. Work with the Global Compliance Manager to ensure Global Field Action program health by providing metrics and reporting to leaders. Work with the Global Compliance Manager to identify and implement process improvements in the Global Field Action program.
DUTIES AND RESPONSIBILITIES:
• Provides compliance expertise for the Division by interpreting government regulations and standards as they apply to the Quality Management System and provide training and consulting. The incumbent will also be required to interface with all sites and functions globally to provide compliance advice on regulations and standards for the Quality Management System.
• May be involved in Government Communication and Audit-related activities: Research and prepare correspondence in response to external government agencies. Lead reviews of corrective action plans for internal and external audit responses, ensuring the responses satisfy company and regulatory requirements. Perform audits and assessments against company and regulatory requirements.
• May be involved in Standards Management: Provide oversight to the Global Standards program. Work with the Global Compliance Manager to identify and implement process improvements in the global Standards Management processes
• Support the department manager in preparing and presenting data for internal and external audits. Conducts project work as required by the Director of Global Compliance to complete team activities and achieve team objectives. May perform additional related duties as assigned.
REQUIRED SKILLS AND EXPERIENCE:
• Excellent working knowledge of current, international, and company regulatory compliance requirements and operating procedures, including (but not limited to) FDA, PMAA, European Medical Device Directive and Medical Device Regulation, and applicable industry Standards.
Proven knowledge and ability to develop standard operating procedures.
Effective facilitation skills to motivate cross-functional teams to meet objectives (for example, execution of field actions/recalls) within expected time-frames.
• Recognized as a Subject Matter Expert in core compliance areas for medical device and/or pharmaceutical regulations
• Proficient computer skills including electronic mail, project management, record keeping, and routine database activity, word processing, spreadsheet, graphics, etc.