Principal Regulatory Affairs Specialist

Job Summary

The Principal Regulatory Affairs 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 and implement global 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 
• 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 
• Experience with digital health and Software as a Medical Device (SaMD)
• 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 1...