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About our client
Our client is a leading medical device company based in Bohemia, New York. The company has marketed products, an experienced management team, and an empowering corporate culture that is focused on the professional development of its employees. This is a great opportunity for the right candidate!
Position	Location
Regulatory Affairs Manager	Bohemia, New York
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Handle all activities involving regulatory affairs with applicable regulatory requirements for Class I and Class II FDA Medical Devices, especially FDA, MDD (Medical Device Directive), Canada and other international countries 2) Track legislation and regulations and inform the Department Director of issues that might affect the organization’s policies 3) Prepare compliance reports to present to the Department Director 4) Interface with divisions & suppliers when necessary, to ensure regulatory compliance 5) Update Canadian Licensing and medical device listings 6) Input and monitor Trackwise for complaint handling through two Direct Reports 7) Oversee and implement regulatory training for the division 8) Assist (as a team member of the product development process) with new product approvals and gather information for licensing and preparation of 510ks 9) Prepare 510ks, Canadian Licensing, technical files, medical device reports and any other regulatory requirements (domestic and foreign) 10) Assist the Department Director with respect to FDA audits and investigations
Requirements
1) Bachelor/Master’s degree plus 3 years of experience, or an equivalent combination of training and experience 2) Certification in RAC a plus 3) 3 – 5 years of relevant work experience 4) Experience in medical device preferred