Device Regulatory Documentation & Compliance Senior Manager

If you're ready to push the boundaries of global health and make a lasting impact, this role at a well-established Medical Technology company could be your next best move.

Proclinical is seeking a dedicated professional to join our client's team as a Device Regulatory Documentation & Compliance Senior Manager. In this role, you will lead the preparation and management of essential documentation for the registration of medical devices and combination products, focusing on compliance with US and EU regulations. This position involves developing regulatory strategies, overseeing documentation processes, and collaborating with cross-functional teams to ensure regulatory compliance.

Responsibilities:

• Lead and manage the team responsible for producing and maintaining regulatory documentation.
• Ensure all documents for medical device registration are accurate and compliant with relevant regulations.
• Collaborate with various departments to develop robust regulatory strategies.
• Monitor regulatory standards and advise on compliance matters.
• Support internal audits and provide training on best practices in regulatory documentation.
• Assist the Regulatory team during interactions with regulatory agencies.
• Organize and lead the Design Review process and prepare related reports.
• Provide necessary documentation for regulatory dossiers.
• Lead cross-functional teams to align documentation with design inputs and international requirements.
• Establish a comprehensive documentation system for accessibility and traceability.
• Coordinate the preparation of documentation for regulatory filings and respond to inquiries from authorities.
• Offer regulatory guidance throughout the product lifecycle, including risk management and post-market surveillance.
• Identify and implement improvements to streamline documentation practices.

Key Skills and Requirements:

• Expertise in managing documentation and compliance for medical devices and combination products.
• Strong understanding of global regulatory requirements and standards.
• Solution-oriented mindset with leadership capabilities.
• Ability to work effectively in a complex, cross-functional organization.
• Excellent communication, leadership, and interpersonal skills.
• Fluent in English, both oral and written.

If you are having difficulty in applying or if you have any questions, please contact Molly Colclough at m.colclough@proclinical.com.

Apply Now:

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Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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