Business Process Owner (BPO), Risk Management - Remote

Overview

The Business Process Owner (BPO) for Risk Management is responsible for ensuring effective implementation of product risk management processes within the Dispensing and Software Technology Solutions business units. This role requires a blend of quality management and engineering skills tailored for medical devices.

In Short

• Lead risk management process activities for product development and maintenance.
• Influence and implement changes across business units based on regulatory observations.
• Participate in design control and change control process activities.
• Monitor performance of product risk management and report to senior leadership.
• Establish training requirements for product risk management.
• Support regulatory inspections and audits.
• Drive continuous process improvements across the organization.
• Collaborate with cross-functional teams and SMEs.
• Benchmark industry trends and best practices.
• Work effectively in a global team environment.

Requirements

• BS/MS degree in life science, engineering, or relevant discipline.
• At least 8 years of experience in medical device risk management.
• Proven experience with ISO 14971 and FDA regulations.
• Strong background in quality strategy and oversight.
• Excellent problem-solving and analytical skills.
• Strong technical writing experience required.
• Ability to develop creative solutions for complex problems.
• Effective communication skills at senior levels.
• Experience leading global teams.
• Ability to influence decision makers across diverse areas.

Benefits

• Competitive compensation package.
• Medical, health, and dental benefits.
• 401k retirement plan.
• Work-life balance with flexible arrangements.
• Support for professional growth and development.
• Inclusive and diverse workplace culture.
• Opportunities to work on impactful health solutions.
• Collaboration with a global team.
• Recognition for contributions and performance.
• Commitment to employee well-being.