Sr. Director, Post- Market Risk Management

Medline • Northfield, MN

23h • $203,000 - $305,000

About The Position

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.

Requirements

• Bachelor’s degree in Engineering, Science, or Technical Field.
• At least 8 years of experience working with QSR/GMP/ISO.
• At least 5 years of management experience.
• 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).

Nice To Haves

• Experience in Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products Industries.

Responsibilities

• Overseeing m anage ment 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 co mpliant 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 f or 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 s ales 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, c omplaint i ntake, c omplaint i nvestigations, r egulatory r eportability, r isk m anagement, and r ecall f ield a ctions.
• 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.
• 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

Benefits

• Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
• 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 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Number of Employees: 5,001-10,000 employees