Regulatory Affairs Specialist, III

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:

 


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* Develop regulatory strategies to achieve market clearance in an effective and efficient manner


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* Prepare, submit, and maintain product registrations, certifications, and approvals to meet US, EU and other regulatory requirements as applicable:      
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+ 510(k) and/or De Novo submissions for FDA
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+ Technical documentation for EU MDR compliance
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+ International product registration activities to meet business objectives
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* Provide regulatory input to support product labeling


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* Monitor new and changing regulatory requirements and ensure the business understands relevant impacts


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* Lead corrective and preventive action (CAPA) efforts as assigned


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Product Development Support:

 


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


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Change Control Management:

 


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* Assess and document regulatory impacts of design changes, manufacturing changes, etc., including related updates to product registrations


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Audits and Inspections:

 


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* Support and participate in internal and external audits and regulatory agency inspections


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QMS Support:

 


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* Complete QMS training activities and provide regulatory expertise to continuous improvement activities


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* Support Lean and Kaizen initiatives


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* Comply with all company policies and procedures


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* Assist with any other duties as assigned


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Qualifications

 

Education:

 


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* Bachelor of Science degree


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Experience:

 


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* 5–7 years of regulatory affairs experience in the medical device industry, preferably with respiratory devices


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


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* Experience with additional global regulatory pathways is preferred


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Technical Skills:

 


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* Strong understanding of medical device product life cycle and regulatory requirements


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