Regulatory Affairs Specialist, IV

Job Summary  The Regulatory Affairs Specialist IV position ensures compliance with global medical device regulations throughout the product lifecycle (Class 2 medical devices, electromechanical devices, patient contact devices, Software as a medical device, as well as digital health related devices).  This role involves developing and executing regulatory strategies, preparing and submitting documentation to regulatory authorities, and maintaining adherence to standards such as FDA, EU MDR, and ISO 13485.   The position requires collaboration with cross-functional teams to support product development, labeling, marketing, and post-market activities, while monitoring regulatory changes and ensuring timely implementation of projects.  Responsibilities  Regulatory Submissions and Compliance: 

• Develop and implement global/worldwide 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 bodies as applicable:       

• International product registration activities to meet business objectives     

• 510(k) submissions for FDA        

• Technical documentation for EU MDR compliance        

• Interface with regulatory agencies (e.g., FDA, Notified Bodies) and respond to inquiries. 

• Provide regulatory input to support product labeling and promotional materials   

• 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:    

• Serve as regulatory lead on product development teams 

• Provide regulatory input throughout the product lifecycle, including design controls, to support regulatory submissions  

• Assess regulatory impact of product changes and provide guidance to cross-functional teams. 

• Advice on regulatory requirements during design, development, and commercialization phases 

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:    

• At least 8 years of regulatory affairs experience in the medical device industry, preferably with mechanical-electrical devices and/or respiratory devices    

• Current experience leading multiple successful 510(k) clearances and CE marking is required   

• Current experience leading international regulatory registrations  

• Experience with digital health and Software as a Medical Device (SaMD) 

 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 com