Contract position: This position acts as a liaison between Global Regulatory Affairs and Engineering, providing technical interpretation of domestic and international regulatory requirements for new product launches and changes throughout the product lifecycle. Responsible for identifying and planning ongoing maintenance tasks required to maintain product licenses and registrations. Responsibilities for the Regulatory Affairs
Requirements for the Regulatory Affairs
- Works closely with Global Regulatory Affairs to identify applicable regulatory requirements, and to translate the requirements into work tasks for Engineering development and maintenance plans.
- Understands new and changing regulations identified by Global Regulatory Affairs. Determines the impact on new product development/maintenance activities and effectively communicates the outcome to Engineering.
- Serves as a resource to the engineering teams during product development to ensure the necessary steps are taken during a project for successful product registrations.
- Participates in the planning and executing product safety and performance standards (e.g., UL, CSA, IEC and ANSI/AAMI.) with third-party laboratories.
- Collaborates with Global Regulatory Affairs to understand "current thinking" of regulatory agencies and to assist Engineering in applying US FDA, European MEDDEV, etc. guidance documents to their designs.
- Accurately populates and maintains the global registration database, to ensure maintenance activities are planned for by Engineering to sustain compliance through a product's lifecycle.
- BS in Engineering or equivalent four-year degree.
- At least 5 years relevant work experience in the medical device field.
- Strong working knowledge of standards relevant to medical device safety and performance; experienced with IEC 60601 standards.
- Previous US 510(K) and Health Canada submission experience is preferred.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.