Regulatory Affairs Director

1 week ago


Dallas, Texas, United States Katalyst Healthcares & Life Sciences Full time
Regulatory Affairs Manager

Katalyst Healthcares & Life Sciences is seeking a highly skilled Regulatory Affairs Manager to lead project submissions for regulatory approvals and drive cross-functional alignment with regulatory ramifications.

Responsibilities:
  • Develop and implement global regulatory strategies for new and modified medical devices, ensuring compliance with US and international regulations.
  • Prepare and submit robust regulatory applications to achieve departmental and organizational objectives, including device labeling and marketing materials.
  • Provide leadership and guidance to RA staff and cross-functional team members, including training and development.
  • Review and assess proposed regulations, communicating new requirements to the organization and ensuring compliance with FDA and international regulations.
  • Support all Company initiatives, including Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Requirements:
  • Bachelor's Degree or equivalent combination of education and experience.
  • 8+ years technical experience, with 6+ years medical device regulatory experience.
  • Extensive experience with US and global medical device regulations and submissions.
  • Strong leadership skills, including goal-setting and providing positive and constructive feedback.
  • 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.


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