Risk Manager, Robert Half

Risk Manager

Robert Half

Location:

United States, Skaneateles, NY

Category:

IT - Administration

Contract Type:

Not provided

Salary:

Not provided

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Job Description:

We are seeking a highly qualified Risk Manager to support in advancing risk management activities within the Front-Line Care Patient Monitoring Portfolio. This role requires a skilled professional with deep subject matter expertise in risk management processes, communication across diverse stakeholders, and ensuring compliance with ISO 14971 standards. The successful candidate will play a pivotal role in maintaining and updating risk management files in alignment with corporate policies and procedures.

Job Responsibility:

Act as a subject matter expert (SME) to assist functional leaders in planning and updating elements of the risk management file
Engage and communicate effectively with a diverse set of stakeholders, including Quality Systems, Risk Project Management (PM), Regulatory Affairs (RA), and Marketing teams
Demonstrate an understanding of the end-to-end process of identifying stakeholder needs, translating these into Design Inputs, and establishing traceability to Design Outputs
Apply operational, functional, and physical architectures to analyze hazardous situations and develop comprehensive risk management frameworks
Utilize a Systems Engineering-driven approach to achieve compliance with ISO 14971 (medical device risk management)
Ensure all activities are conducted in strict accordance with design control and risk management policies and procedures

Requirements:

Proven ability to manage cross-functional collaboration with stakeholders across various business functions
Strong understanding of risk and quality management systems
Demonstrated knowledge of processes involving stakeholder needs identification, conversion into design specifications, and traceability to outputs
Background and expertise in operational, functional, and physical systems architecture, particularly as it relates to identifying hazardous situations in medical device portfolios
Extensive experience with ISO 14971 compliance processes and systems engineering best practices

Nice to have:

Outstanding communication and interpersonal skills
Proactive self-starter with strong analytical and organizational skills
Aptitude for working in fast-paced, complex environments with a high degree of professionalism and attention to detail

What we offer:

Medical, vision, dental, and life and disability insurance
Eligibility to enroll in company 401(k) plan

Additional Information:

Job Posted:

March 22, 2025

Employment Type:

Fulltime

Work Type:

On-site work

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