Post-Market Risk Management Manager

We are the people who give possibilities purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

Post Market Risk Manager is responsible for implementing and ensuring compliance with design control and risk management requirements throughout all phases of the life cycle of BD's dispensing medical devices and solutions. They will lead cross-functional teams during the design and development and post-market risk management reviews to ensure that all necessary risk management activities are carried out in accordance with the quality system. The role will lead and coach cross functional teams on risk management processes that support BD's commitment to innovation and patient safety. Post Market Risk Manager will apply a risk-based approach throughout the development phases and facilitate the risk management deliverables to support regulatory filings, product launch, and post-market surveillance risk management framework.

• Lead multi-functional discussions such as with engineering, design, commercial, and product teams to ensure that all hazards associated with products are identified, risks are estimated, evaluated, controlled, and documented. Monitor that risk controls are implemented, verified, and validated for products in development and verify the effectiveness of risk control measures throughout the product life cycle.

• Maintain ISO 14971 compliant risk management files and serve as a subject matter expert in design control and post-market risk management process and execution.

• Collaborate on design, development, and validation strategies, ensuring documentation aligns with Quality Management Systems compliance requirements.

• Lead remediation efforts for updating risk management documents and the implementation of the FMEA process.

• Perform and document Risk Management Reviews to communicate results of the risk management process to cross-functional teams.

• Ensure harmonization of risk management strategies across projects and their lifecycle by communicating with other Risk team members.

• Identify opportunities for continuous improvement of the Risk Management Process.

• Facilitate and provide ongoing training on standards/processes as needed for other associates or functions.

• Assist with strategic initiatives and planning.

• Mentor and coach post-market risk management and cross functional teams on risk management processes.

Education and Experience:

• Bachelor’s degree in engineering and 5 years of Quality, Design Controls, Risk Management experience within the medical device industry.

• Minimum of 5 years of Post-Market Quality, specifically complaint trending/data analytics and risk assessments.

• Two years of people management experience.

• Advanced knowledge of risk management, design controls, regulatory, quality engineering polices, principles and standard methodologies

• Advanced knowledge of FDA/ISO applicable guidance, regulations and standards including ISO 14971, ISO 13485, FDA 21 CFR 820.

• The position requires strong oral and written communication and interpersonal skills, technical problem solving, the ability to work in teams, critical thinking, the ability to adapt to a rapidly changing environment, and desire to contribute to meaningful and innovative products

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture wher