Job Description
Job Title: Regulatory Affairs Specialist
The Regulatory Affairs Specialist plays a key role in maintaining regulatory compliance for a growing medical device organization. This individual develops and implements regulatory policies and procedures that meet the requirements of the countries where products are distributed, with a strong focus on medical devices. The role works proactively and collaboratively with Marketing, Sales, Operations, Quality, Engineering, and R&D to support successful regulatory submissions, approvals, and ongoing compliance.
Responsibilities
+ Direct coordination and preparation of document packages for regulatory submissions from all areas of the company, including internal audits and inspections.
+ Prepare and manage 510(k) and PMA submissions for the FDA, ensuring completeness, accuracy, and timely delivery.
+ Create and maintain Technical Documentation for Europe, including Technical Files and Design Dossiers for medical dev...
The Regulatory Affairs Specialist plays a key role in maintaining regulatory compliance for a growing medical device organization. This individual develops and implements regulatory policies and procedures that meet the requirements of the countries where products are distributed, with a strong focus on medical devices. The role works proactively and collaboratively with Marketing, Sales, Operations, Quality, Engineering, and R&D to support successful regulatory submissions, approvals, and ongoing compliance.
Responsibilities
+ Direct coordination and preparation of document packages for regulatory submissions from all areas of the company, including internal audits and inspections.
+ Prepare and manage 510(k) and PMA submissions for the FDA, ensuring completeness, accuracy, and timely delivery.
+ Create and maintain Technical Documentation for Europe, including Technical Files and Design Dossiers for medical dev...
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