Regulatory Affairs Manager

Responsibilities :

• This position leads project submissions for regulatory approvals and acts independently to identify and resolve problems
• This new team member will apply advanced regulatory expertise to guide cross-functional partners and demonstrate strategic thinking and creativity in support of programs
• Develops sound global regulatory strategies for new and modified medical devices
• Prepares robust regulatory applications to achieve departmental and organizational objectives
• Creates, reviews and approves engineering changes
• Provides leadership and guidance (including training) to other members of the RA staff as well as to cross-functional team members and development teams
• Reviews device labeling and marketing materials for compliance with FDA submissions and applicable regulations
• Provides global strategic input to development teams (including all feasible alternatives and associated risks)
• Drives cross functional alignment with issues that could have Regulatory ramifications
• Independently interacts and builds partnerships with competent authorities (FDA, and other regulatory agencies)
• Builds strategic partnerships to further departmental and organizational objectives
• Reviews of product and manufacturing changes for compliance with applicable regulations (Change Control)
• Reviews protocols and reports to support regulatory submissions
• Assesses proposed regulations and communicates new requirements to the organization
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
• Complies with Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors

Education and Experience :

• Bachelor's Degree OR an equivalent combination of education and experience
• years technical experience
• years medical device regulatory experience
• Extensive experience with US and global medical device regulations and submissions
• Ability to work in a highly matrixed and geographically diverse business environment
• Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results
• Ability to work effectively within a team in a fast-paced changing environment
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
• Multi-tasks, prioritizes and meets deadlines in timely manner
30+ days ago