PURPOSE AND SCOPE:

Responsible for the day-to-day management of assigned staff and business processes. This is a hands on Level 1 Manager who leads teams and completes assigned items (Complaints, MDR Review, and project work). Ensures timely submission of adverse reports (MDR’s/ADE’s/FAR’s) across all Fresenius product lines as required. Ensures processes and systems are established and effective to receive, review, handle, and distribute high risk complaints across the company. Helps provide customer support and serves as a liaison between manufacturing facilities, the medical department, and customers/patients regarding adverse events and potential product problems. 

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Manages the tactical execution of short- and long-term objectives through the coordination of activities with a direct responsibility for results, including costs, methods, and staffing.

Provides day-to-day oversight of assigned Post Market Surveillance staff responsible for receiving, reviewing, and evaluating product complaints from a clinical perspective to support the overall Post Market Compliant Management process.

Provides leadership, coaching, and development plans for all direct reports to maintain an engaged and productive workforce; partnering with Human Resources on employee matters.

Follows processes and operational policies in selecting methods and techniques for obtaining solutions. Interprets and recommends change to policies and establishes procedures that effect immediate organization(s).

Develops staff, manages performance, provides on going feedback and is responsible for annual assessment for direct reports utilizing the company’s performance management tools.

Assigns daily work, goals, and objectives to Supervisor and Post Market Surveillance staff.

Reviews adverse events/reportable malfunctions and provides MDR/ADE/FAR file review to support the overall Post Market Surveillance Management process, as required.

Ensures timely submission of regulatory reports, as required.

Providex training to staff and other resources across the company on Post Market Clinical/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

Responsible for timely closure/review of files and ensures that all pertinent information is contained within the file prior to closure.

Participates in department CAPA activities.

Participates in department SOP revision/creation via change notice process.

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.

Interacts with internal departments and external customers; particularly in problem resolution.  Acts as an advisor to subordinate(s) to meet schedules and/or resolve technical problems.  Responsible for hiring, coaching and counseling employees, including performance reviews, disciplinary action and terminations.

Provides technical guidance.

Assists with various projects as assigned.

Other duties as assigned.

Additional responsibilities may include focus on one or more departments or locations.  See applicable addendum for department or location specific functions.

PHYSICAL DEMANDS AND WORKING CONDITIONS:

The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

SUPERVISION:

Responsible for the direct supervision of various levels of Post Market Surveillance staff.

EDUCATION:

Bachelor’s Degree required.  Clinical dialysis, product knowledge, or RN strongly preferred.

EXPERIENCE AND REQUIRED SKILLS:

Minimum 6 – 8 years of related post market surveillance experience; healthcare industry or healthcare-related experience with exposure to the regulated portion of the healthcare industry desired; 3+ years of supervisory/management experience preferred.

Requires understanding of regulatory obligations for compliance within the scope of the department.

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 and ability to read, interpret, and understand medical records.

Ability to prepare and document clinical reports. 

Attention to detail required and ability to make decisions with limited information.

Prior experience working with the FDA preferred. 

Team lead experience preferred.

Detailed knowledge of industry best practices for medical product complaint handling.

Ability to manage ongoing multiple tasks, be responsive to critical situations and changing priorities.

Excellent problem solving skills.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.