Job Title
Director of Regulatory Affairs
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Overview
The Director of Regulatory Affairs will lead the company's global regulatory strategy. This role involves developing and driving regulatory strategies to support product development, commercialization, and market expansion activities.
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Responsibilities
* Develop Global Regulatory Strategies
o Support product development and commercialization
* Manage Regulatory Submissions
o CE marking, FDA 510(k)/PMA, and other global submissions
* Serve as Primary Liaison with Regulatory Authorities
* Lead High-Performing Regulatory Team
* Monitor Evolving Regulatory Requirements
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Qualifications
Key qualifications include:
* Minimum 10 years' experience in Regulatory Affairs within medical device industry
* Proven success in preparing and leading regulatory submissions for Class II/III devices
* Strong understanding of global regulatory environment, including emerging markets