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 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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