Job Summary
Responsible for leading and managing the Global Process, Systems & Center of Excellence team supporting postmarket processes including but not limited to complaint management, investigations, failure analysis, device vigilance, regulatory reporting and pharmacovigilance processes to assure regulatory compliance, process standardization, and consistent implementation throughout the organization and across all Medline’s product portfolios.
Provide management oversight for the development, ownership, maintenance, harmonization, and implementation of global postmarket processes, procedures, work instructions, reportability frameworks, coding standards, and associated governance. Provide management oversight for global complaint/AE IT system governance, including business and user requirements, fields, workflows, codes, lists of values, business rules, data standards, integrations, configuration requirements, and system change management.
Provides management oversight of the Global Process, Systems & Center of Excellence team and lead global governance, best practices, process standardization, training support, inspection readiness, compliance oversight, global harmonization, acquisition integrations and continuous improvement.
Job Description
MAJOR RESPONSIBILITIES:
- Manage Medline's development, governance, implementation, and continuous improvement of global postmarket surveillance including complaint management, investigation, device vigilance, regulatory reporting and pharmacovigilance processes and strategies. Identify, lead, and drive opportunities to improve global process effectiveness, compliance, standardization, and harmonization.
- Lead the Center of Excellence for processes, systems, and standards, including best practices, global process standardization, global harmonization, process and procedures, device vigilance reportability framework, coding standards and governance, training program, process compliance, and continuous improvement.
- Manage Global Process, Systems & Center of Excellence personnel responsible for the development, ownership, maintenance, and harmonization of global procedures, work instructions, process requirements, reportability frameworks, coding standards, and associated controlled documentation.
- Manage complaint/AE IT system governance, including user and business requirements, fields, workflows, codes, lists of values, business rules, integrations, configuration requirements, system enhancements, and change management.
- Work with global and cross-functional partners to ensure adequate implementation, integration of acquisitions, governance, and continuous improvement of Medline's processes and systems to meet global needs and changing regulatory requirements.
- Lead development and maintenance of governance mechanisms, including operational reviews, management reviews, process performance monitoring, compliance oversight, and escalation of identified process, system, or data issues.
- Lead cross-functional integration management of processes and systems, partnering with Quality, Regulatory Affairs, Medical/Clinical, Product Divisions, Operations, IT, and other applicable functions to ensure requirements and process interfaces are appropriately defined and maintained.
- Stay current with applicable regulatory requirements and standards and assess changes to determine potential impact to global procedures, work instructions, frameworks, standards, and governance processes, to maintain alignment with applicable requirements and current practices.
- Provide global support for FDA, Notified Body, MDSAP, and other applicable regulatory inspections and audits. Lead and support inspection readiness and process compliance activities, including assessment of process and system controls, identification of compliance opportunities, support of corrective actions, and evaluation of the effectiveness of implemented improvements.
- Manage global implementation activities associated with new or revised processes, procedures, systems, regulatory requirements, or system integrations. Develop training and guidance to personnel.
- Lead evaluation and implementation of process, procedure, coding, or system changes resulting from regulatory changes, inspection findings, corrective actions, quality events, identified compliance risks, trend signals, or other event-driven improvement needs.
- Establish and maintain governance to ensure changes to processes, systems, fields, workflows, codes, lists of values, and business rules are appropriately evaluated for cross-functional and global impact prior to implementation.
- Management responsibilities:
- Oversee major projects/programs/outcomes.
- Budget responsibility.
- Interpret and execute policies for departments/projects; develop, recommend, and implement new policies or modifications to existing policies.
- Provide general guidelines and parameters for staff functioning.
- 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.
MINIMUM JOB REQUIREMENTS
Education
- Bachelor's degree with a scientific, engineering, Quality, regulatory, or related technical background.
Certification / Licensure
N/A
Work Experience
- At least 5 years of experience within medical device and pharmaceutical Quality Management Systems, including experience with postmarket surveillance, complaint management, regulatory reporting, Quality Systems, process governance, or related regulated processes.
- At least 2 years of experience managing people, including hiring, developing, motivating, and directing people as they work.
- Experience with applicable FDA requirements and ISO 13485, MDSAP and EU MDR requirements.
- Experience with development, implementation, or governance of global Quality processes and procedures.
- Experience with FDA inspections and FDA 483 response activities.
- Experience working within global and cross-functional quality/regulatory environments.
- Knowledge / Skills / Abilities
- Demonstrated knowledge of post-market surveillance processes, complaint management, AE case processing, regulatory reporting processes across devices, pharma, and/pr combination products, Quality Management Systems, and global process governance.
- Demonstrated ability to develop, implement, govern, and harmonize complex global processes and procedures.
- Knowledge of electronic complaint/AE/Quality Management Systems and governance of system workflows, fields, codes, lists of values, business rules, and data requirements.
- Ability to translate regulatory, compliance, business, and operational requirements into global processes and system requirements.
- Strong analytical and problem-solving capability with the ability to identify process, system, data, and compliance risks and drive sustainable improvements.
- Position may require travel for business purposes, including domestic and/or international travel.
PREFERRED JOB REQUIREMENTS
Education
Bachelor's degree in engineering, biological sciences, life sciences, Quality, regulatory affairs, or related scientific/technical discipline.
Certification / Licensure
None.
- Work Experience
- Experience with system implementation, integration, configuration, validation/testing, or change management.
- Experience leading global process harmonization or standardization initiatives across multiple businesses, sites, or geographic regions.
- Experience integrating acquisitions or new business units into global Quality processes and systems.
- Knowledge / Skills / Abilities
- Advanced Microsoft Word and Excel experience.
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:
$154,000.00 - $231,000.00 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 roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here.
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.