Description

Job Summary

    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.  

Responsibilities

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 labeling   
• 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 

QMS Support:   

• Complete QMS training activities and provide regulatory expertise to continuous improvement activities   
• Support Lean and Kaizen initiatives   

• Comply with all company policies and procedures   
• Assist with any other duties as assigned 

Qualifications

Education:   

• Bachelor of Science degree 

Experience:   

• 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  
• Experience with additional global regulatory pathways is preferred 

Technical Skills:   

• 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 

Personal Attributes:   

• 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