Management 1 - Post Market Surveillance

Supervisor Post Market Surveillance

Responsibilities:

• Supervises the daily operations of assigned Post Market Surveillance team, including but not limited to: establishing mutual goals, assigning tasks and maintaining schedules. Assists the Manager, Post market Surveillance in the day-to-day management of the department.
• Ensures all daily activities for the team are complete, accurate, and completed in a timely manner.
• Ensures reviews of complaint investigations from the manufacturing plants are timely, accurate and consistent.
• Works closely with the Manager, Post Market Surveillance to establish weekly Quality Performance Metrics and Complaint Reports which are generated on time and are accurate. Analyzes quality data to identify tends and reports them to management in a timely fashion.
• Supports the Corporate Corrective & Preventative Actions (CAPA) program, with particular emphasis on CAPAs escalated from Complaints.
• Ensures Corporate Quality Engineering department SOPs are up-to-date, accurate, and followed.
• Provide training to staff and other resources across FMCNA/RTG on Post Market Surveillance l/Regulatory activities as required
• Applies solid knowledge of drug/device regulatory requirements in order to make decisions and elevate incidents to next level (Medical Case Review) as required.
• Ensures the timely closure/review of files and ensures that all pertinent information is contained within the file prior to closure.
• Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.
• Ensures all employees within the assigned team(s) understand and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations; establishing and maintaining effective internal systems and controls to promote compliance.
• Provides direct supervision of the assigned team(s) through ongoing leadership and guidance; partnering with Human Resources on employee matters.
• Provides direction to employees, according to established policies, procedures and management guidance. Supervises day-to-day operations of employees. Responsible for hiring, coaching and counseling employees, including performance reviews, disciplinary action and terminations.
• Administers company policies, processes and procedures that directly affect subordinate employees and the workflow unit. Recommends changes to unit or sub-unit policies.
• Provide technical guidance.
• Responsible for the direct supervision of various levels of Post Market Surveillance staff.

Qualifications:

• Bachelor's degree requiered, Clinical dialysis, product knowledge, or RN strongly preferred.
• Bilingual (English/Spanish) Fluent in English.
• Minimum 2 – 3 years of experience in a post market surveillance role, preferably at a senior level; or 1 – 3 years of experience as a supervisor. Healthcare industry or healthcare-related experience with exposure to the regulated portion of the healthcare industry desired.
• Requires understanding of regulatory obligations for compliance within the scope of the department (21 CFR 820.198 and 21 CFR 211).
• Requires a solid understanding of drug/device safety regulations and requirements.
• Strong interpersonal skills with the ability to lead teams.
• Must be self-driven to meet business commitments, and timelines.
• Familiarity with medical terminology.
• Attention to detail required and ability to make decisions with limited information.
• Prior experience working with the FDA preferred