Sr. Director, Post- Market Risk Management

Job Summary Responsible for overseeing and directing strategic planning for large and highly complex Regulatory Compliance – Post-Market Risk Management Organization; ensuring regulatory, quality, and compliance for applicable products, processes, and services for assigned departments. Overseeing management of global regulatory compliance Post-Market Risk Management areas that include the Complaint Intake, Complaint Investigations, Medical Device and Drug Regulatory Reportability, Risk Management, and Recall Field Action handle. Job Description Responsibilities: Overseeing management of global regulatory compliance Post-Market Risk Management areas that include the Complaint Intake, Complaint Investigations, Medical Device and Drug Regulatory Reportability, Risk Management, and Recall Field Action. Ensure that the program remains compliant with FDA regulations, global regulations, and ISO standards. Communicate regulatory compliance trends to senior management and executive management. Provide leadership and expertise in the development of strategy for the applicable organizations; motivate and engage others around team vision and manage others to ensure execution. Provide leadership, support, and expertise to Medline divisional, manufacturing and sales teams in implementing Risk Management and Post-Market Operations. Host FDA/ global regulatory inspections at Medline in relation to Post-Market Risk Management areas as needed. Oversee and delegate technical projects such as remediation, complaint intake, complaint investigations, regulatory reportability, risk management, and recall field actions. Support Sales and business units in communication with customers in relation to field actions as well as other post-market and risk management activities. Lead Post-Market Clinical MDR evaluations and risk management activities. Management responsibilities include: Typically, manages through multiple Managers. Provides leadership and management to one or more major departments of an operating unit or to a department that has system-wide accountability. Strategic, tactical and operational planning (12 + months) for the function or department; Direct budgetary responsibility for one or more departments, functions or major projects/programs; Interpret and execute policies for departments/projects and develops; Recommend and implement new policies or modifications to existing policies; Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies Qualifications: Bachelor’s degree in Engineering, Science, or Technical Field. Work Experience At least 8 years of experience working with QSR/GMP/ISO. At least 5 years of management experience. Knowledge / Skills / Abilities Experience analyzing and reporting data in order to identify issues, trends, or exceptions to drive improvement of results and find solutions. Experience controlling and coordinating concurrent projects, competing priorities and critical deadlines. Advanced level skill in Microsoft Excel (for example: using AVERAGE function, merging and centering cells, printing centered page and/or creating a pivot table). Position requires travel up to 30% of the time for business purposes (within state, out of state and/or internationally). Preferred Qualifications: Experience in Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products Industries. Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $203,000.00 - $305,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here . For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here . Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.