Manager, Regulatory Affairs (03)

Position:  Global healthcare company is seeking a dynamic, self starting individual to assume ownership of assigned regulatory projects. In this self directed project role the selected individual will be responsible to perform the following functions: Provide global regulatory input for new product development and on-market support of software controlled medical device products including software accessories, interfaces, and associated single use medical devices.

In the performance of those duties the individual will execute regulatory plans for those projects including new products and maintenance of licenses/authorizations for existing marketing products. Additionally, he/she will ensure that regulatory submissions and design documentation meet corporate and departmental standards with respect to technical expertise and will resolve any conflicts relating to the design.

To be considered for this position you must possess a bachelor’s degree in engineering or in a scientific discipline in addition to 5-7 years directly transferable 510k experience with software driven medical device products for a global market. Proven ability to mentor, lead, and positively influence others in meeting project timelines will be essential for success.