Regulatory Affairs Specialist

2 days ago


Santa Clarita, California, United States huMannity Medtec Full time
Principal Regulatory Affairs Specialist

At huMannity Medtec, we are committed to developing life-enhancing medical technologies that address unmet healthcare needs. We are seeking an experienced and highly motivated Principal Regulatory Affairs Specialist to join our team and contribute to the development and demonstration of exciting technologies from ideation through clinical trials.

Key Responsibilities:

  • Lead risk management activities, including the creation and maintenance of risk management documentation, such as FMEAs, hazard analysis, plans, reports, and trace matrices in accordance with ISO 14971 and cybersecurity requirements.
  • Participate in development teams and provide input to ensure that regulatory requirements are incorporated in the product development process for Class III Medical Devices.
  • Create and submit regulatory submissions based on the regulatory strategy.
  • Review and approve engineering change order documents.
  • Review promotional material and labeling for regulatory compliance.
  • Assist with negotiations and interactions with regulatory authorities during the development and review process to ensure submission approval.
  • Work with R&D on product V&V activities, including sterilization, packaging/labeling, transit testing, real-time/accelerated aging, as well as review and approval of engineering protocols and reports.
  • Responsible for product packaging/labeling requirements and ensuring materials conform with applicable regulatory requirements.
  • Maintain regulatory documentation and registrations.
  • Drive improvements in quality system processes and procedures.

Requirements:

  • Bachelor's degree and 8+ years of experience in the medical device industry, Class III preferred.
  • Demonstrated command and knowledge of FDA and ISO medical device quality system requirements (21CFR820, ISO 13485, and ISO 14971) and audit programs (MDSAP).
  • Must be able to manage multiple and competing priorities and manage programs with minimal oversight.
  • Experienced leading design assurance activities for new product development.
  • Critical Thinker, highly organized, efficient, and self-motivated.
  • Experience with SaMD and Digital Health apps.
  • Demonstrated Microsoft Word, Excel, Office, PowerPoint, and Adobe software skills.


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