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 5+ 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 regulators
- Knowledge of US 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