Remote Risk Management Specialist - ISO 14971 Expert

RXinsider LTD.; Allentown (Lehigh County); On-site; USD 105,000 - 111,000; Full time

Benefits offered by this job

Healthcare

401(k)

Tuition reimbursement

Job summary

B. Braun Medical Inc., a leader in infusion therapy, is seeking a Quality/Risk professional to author ISO14971 based safety risk assessments and drive postmarket risk management across medical devices and combination products.

You will maintain and optimize risk management documentation, work with quality, manufacturing, R&D and engineering to support new product development and portfolio sustenance, and ensure conformity with ISO 14971, ICH Q9, Usability and Cybersecurity standards.

Qualifications

• Bachelor's degree required; Master's preferred.
• 6–8 years related experience required.
• Applicable industry/professional certification preferred.
• Regular and predictable attendance
• Frequent travel and non-compete agreements; ability to work non-standard schedule

Responsibilities

• Author ISO14971 compliant safety risk assessments.
• Act as postmarket risk management subject matter expert.
• Identify product and process risks and drive improvement.
• Maintain risk management documentation for medical devices, pharmaceuticals and combination products.
• Collaborate with quality, manufacturing, R&D and engineering to support new product development and sustaining portfolio.

Skills

ISO 14971 risk assessment

Postmarket risk management

Risk management knowledge

Quality systems familiarity

Education

Bachelor's degree required

Master's degree preferred

Job description

B. Braun Medical Inc., a leader in infusion therapy, is seeking a Quality/Risk professional to author ISO14971 based safety risk assessments and drive postmarket risk management across medical devices and combination products.

You will maintain and optimize risk management documentation, work with quality, manufacturing, R&D and engineering to support new product development and portfolio sustenance, and ensure conformity with ISO 14971, ICH Q9, Usability and Cybersecurity standards.