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Regulatory Affairs Expert

1 month ago

Santa Clarita, California, United States huMannity Medtec Full time
About the Role

At huMannity Medtec, we are pioneers in life-enhancing medical technologies for underserved healthcare needs. We are seeking a highly motivated and experienced Principal Regulatory Affairs Specialist to join our team of engineers, scientists, and medical device experts.

This is an excellent opportunity to make a difference in people's lives by developing and demonstrating innovative technologies from ideation through clinical trials. As a key member of our team, you will be responsible for participating in product development projects, evaluating document change orders, drafting regulatory submissions, and supporting regulatory-related projects.

Main 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.