Regulatory Affairs Manager

Responsibilities:This position leads project submissions for regulatory approvals and acts independently to identify and resolve problemsThis new team member will apply advanced regulatory expertise to guide cross-functional partners and demonstrate strategic thinking and creativity in support of programsDevelops sound global regulatory strategies for new and modified medical devicesPrepares robust regulatory applications to achieve departmental and organizational objectivesCreates, reviews and approves engineering changesProvides leadership and guidance (including training) to other members of the RA staff as well as to cross-functional team members and development teamsReviews device labeling and marketing materials for compliance with FDA submissions and applicable regulationsProvides global strategic input to development teams (including all feasible alternatives and associated risks)Drives cross functional alignment with issues that could have Regulatory ramificationsIndependently interacts and builds partnerships with competent authorities (FDA, and other regulatory agencies)Builds strategic partnerships to further departmental and organizational objectivesReviews of product and manufacturing changes for compliance with applicable regulations (Change Control)Reviews protocols and reports to support regulatory submissionsAssesses proposed regulations and communicates new requirements to the organizationSupport all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirementsComplies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignmentsMaintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendorsEducation and Experience:Bachelor's Degree OR an equivalent combination of education and experience8+ years technical experience6+ years medical device regulatory experienceExtensive experience with US and global medical device regulations and submissionsAbility to work in a highly matrixed and geographically diverse business environmentStrong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business resultsAbility to work effectively within a team in a fast-paced changing environmentStrong verbal and written communications with ability to effectively communicate at multiple levels in the organizationMulti-tasks, prioritizes and meets deadlines in timely manner