Regulatory Affairs Specialist III

2 days ago

Boys Town, NE, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • The Regulatory Affairs Level III (Senior Specialist) position is responsible for global product registrations and ensuring regulatory compliance in the design, manufacturing, and sales of medical devices (including Class I and II devices, software as a medical device, and de novo devices).
  • The role includes obtaining and maintaining regulatory approvals, supporting quality management system (QMS) objectives, and ensuring adherence to applicable regulatory standards.
  • Develop regulatory strategies to achieve market clearance in an effective and efficient manner.
  • Prepare, submit, and maintain product registrations, certifications, and approvals to meet US, EU, and other regulatory requirements as applicable:
  • 510(k) and/or De Novo submissions for FDA.
  • Technical documentation for EU MDR compliance.
  • International product registration activities to meet business objectives.
  • Provide regulatory input to support product labeling.
  • Monitor new and changing regulatory requirements and ensure the business understands relevant impacts.
  • Lead corrective and preventive action (CAPA) efforts as assigned.
  • Provide regulatory input throughout the product lifecycle, including design controls, to support regulatory submissions.
  • ssess and document regulatory impacts of design changes, manufacturing changes, etc., including related updates to product registrations.
Requirements:
  • Bachelor of Science degree.
  • 5-7 years of regulatory affairs experience in the medical device industry, preferably with respiratory devices.
  • Current experience leading multiple successful 510(k) clearances and CE marking is required.
  • Strong understanding of medical device product life cycle and regulatory requirements.
  • In-depth knowledge of ISO 13485, FDA regulations (including 21 CFR Part 820), and EU MDR.
  • Knowledge of ISO 14971 risk management for medical devices.
  • Proficiency in database systems and advanced Microsoft Excel skills for reporting and analysis.
  • Understanding of continuous improvement principles.
  • Strong verbal and written communication skills, with the ability to articulate complex technical issues clearly and effectively to cross-functional teams and regulatory bodies.
  • Strong analytical and critical thinking skills, with the ability to resolve complex complaints and implement long-term solutions.
  • High level of attention to detail and accuracy, particularly when preparing regulatory submissions.

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