Regulatory Affairs Specialist III

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).
• The role includes obtaining and maintaining regulatory approvals, supporting quality management system (QMS) objectives, and ensuring adherence to applicable regulatory standards.
• Regulatory Submissions and Compliance:
  • 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 labelling.
  • Monitor new and changing regulatory requirements and ensure the business understands relevant impacts.
  • Lead corrective and preventive action (CAPA) efforts as assigned.
• Product Development Support:
  • Provide regulatory input throughout the product lifecycle, including design controls, to support regulatory submissions.
• Change Control Management:
  • Assess and document regulatory impacts of design changes, manufacturing changes, etc., including related updates to product registrations.
• Audits and Inspections:
  • Support and participate in internal and external audits and regulatory agency inspections.

• Bachelor of Science degree.
• 5-7 years of regulatory affairs experience in medical device industry, preferably with respiratory devices.
• 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.

• Seniority level:
  Mid-Senior level
• Employment type:
  
  Contract
• Job function:
  Legal
• Industries:
  Pharmaceutical Manufacturing
• Location:
  
  Libertyville, IL