Global Risk Management Process Lead

The lead collaborates closely with cross-functional teams to assess new product risks, update hazard analyses, and verify that risk controls are effectively implemented. They facilitate or attend design reviews, support usability and human factors integration, and prepare documentation for audits or regulatory submissions. The role also involves mentoring teams on risk tools like dFMEA, pFMEA, Hazard Analysis and tracking metrics for management review, and ensuring that both medical device/IVD and RUO product lines maintain compliant and efficient risk management practices.

How You’ll Make An Impact: 

Risk Management System Development

• Develop and maintain global risk management procedures, templates, and tools in alignment with ISO 14971 and ISO 13485.
• Lead the creation and continuous improvement of risk management policies applicable to IVD and non-IVD (RUO) products.

Product Lifecycle Integration

• Ensure risk management is embedded in all phases: design, development, manufacturing, validation, distribution, and post-market.
• Oversee the development and maintenance of Risk Management Files (RMFs) for both regulated and RUO products.

Compliance & Audit Readiness

• Facilitate and/or conduct gap analyses of existing risk files and align them with evolving standards and regulations.
• Prepare and/or support documentation and functional teams for regulatory submissions and audits, including MDSAP and FDA inspections.

Cross-Functional Collaboration

• Partner with R&D, QA/RA, Manufacturing, and Global Product Support to ensure risk controls are effectively implemented.
• Support usability engineering and human factors integration per IEC 62366 and ISO 24971.

Training & Communication

• Deliver training on risk management principles, tools (e.g., FMEA, hazard analysis), and regulatory expectations.
• Develop communication plans to inform stakeholders of changes in risk management procedures.

Management Review & Metrics

• Provide risk management metrics and insights for management review to ensure ongoing effectiveness.
• Define and document risk acceptability criteria based on international standards, state of the art, and stakeholder needs.

What You Bring:

• Education: Bachelor’s degree in Biomedical, Mechanical, Systems Engineering or related field.
• Work Experience: 8+ years experience or equivalent combination of education and experience.
• Certification in Risk Management is highly desirable.
• Advanced knowledge of regulatory standards (e.g., ISO 14971, FDA regulations and industry best practices).
• Experience consolidating and simplifying risk management processes and documentation
• Strong communication and interpersonal skills, with the ability to work collaboratively in a team environment.

Total Rewards Package: At Bio-Rad, we’re empowered by our purpose and recognize that our employees are as well. That’s why we offer a competitive and comprehensive Total Rewards Program that provides value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Bio-Rad's robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee’s work and life cycle.

Benefits: We’re proud to offer a variety of options, including competitive medical plans for you and your family, free HSA funds, a new fertility offering with stipend, group life and disability,  paid parental leave, 401k plus profit sharing, an employee stock purchase program, a new upgraded and streamlined mental health platform, extensive learning and development opportunities, education benefits, student debt relief program, pet insurance, wellness challenges and support, paid time off, Employee Resource Groups (ERG’s), and more! 

Compensation: The estimated annual salary for this position is $133,000 to $175,000 at the time of posting. This range is inclusive of all geographic locations within the United States*.  Actual compensation will be provided in writing at the time of an offer, if applicable, and is based on several factors we believe fairly and accurately impact compenstion, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors. This position is eligible for a variable annual bonus, which is dependent upon achievement of your individual objectives and Company performance. 

*Minimum reflects our lowest paying locations, and the top end reflects our highest paying locations. The range in your geographic location will vary but will be within the indicated ranges. 

Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see. 

EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with physical or mental disabilities, and people of all race, color, sex, sexual orientation, gender identity, religion, national origin and citizenship status are encouraged to apply.

Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

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