Regulatory Affairs Manager

2 months ago


Dallas, United States Katalyst Healthcares & Life Sciences Full time

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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