Remote Program Manager ~ Medical Device Risk Management

My client is expanding and seeks a leader to support regulatory and quality efforts for medical devices. The ideal candidate will take on the following tasks:

Oversee the risk management process including risk identification, analysis, mitigation, monitoring and reduction

Lead the risk management activities and establish system for risk documentation

Collaborate with functional teams in developing and executing design risk analyses for Design Plans, Design Reviews, Change Orders and dFMEA, pFMEA and uFMEA.

Advise R&D personnel on risk management activities throughout the product lifecycle

Support risk management audits when working with external business partners and where needed regulatory authorities

Keep abreast of emerging regulatory and industry trends regarding risk management

Perform risk assessment as part of post-market monitoring in support of complaint risk analysis, field corrective actions, design changes, product life cycle sustaining efforts, and others.

The ideal candidate will possess the following qualities:

BS degree and 7+ years of risk management design controls, systems engineering, or quality assurance experience in medical device, pharma or biotech

In depth knowledge of 21 CFR 820, ISO 13485 and ISO 14971 requirements

Solid knowledge of US FDA regulations for Class II and Class III medical devices and experience working with EU Notified body

Knowledge of U.S. and European and International regulations and standards

Experience interacting with FDA and other regulatory agencies

Solid understanding of manufacturing, change control and risk management, and an awareness of regulatory trends