Regulatory Affairs Manager

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Job description

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 U.S. 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

8+ years technical experience

6+ 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

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