Hobson Prior is seeking a Quality and Regulatory Manager to oversee quality and regulatory activities for software medical devices. You will oversee all quality and regulatory activities related to software medical devices. You will play a critical role in maintaining regulatory compliance, driving continuous quality improvement, and supporting the development and commercialization of innovative products. This role that requires a strong understanding of medical device regulations and standards, particularly as they relate to software.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• Develop, implement, and maintain the Quality Management System (QMS) in compliance with regulatory standards (e.g., ISO 13485, FDA 21 CFR Part 820, and EU MDR).
• Prepare and manage regulatory submissions for product approvals, including FDA, CE Mark, and other global markets as needed.
• Collaborate with cross-functional teams to ensure product development processes meet regulatory and quality requirements (e.g., IEC 62304 for software development).
• Conduct internal and external audits to ensure compliance with applicable regulations and standards.
• Lead risk management activities, including creating and maintaining risk management files in line with ISO 14971.
• Provide guidance and training to staff on regulatory and quality requirements to foster a culture of compliance and continuous improvement.
• Monitor regulatory changes and ensure the company adapts to new or updated regulations and standards.
• Serve as the primary point of contact with regulatory bodies and notified bodies during audits, inspections, and submissions.

Qualifications:

• Bachelor's or master's degree in engineering, Life Sciences, or a related field.
• 5+ years of experience in quality assurance or regulatory affairs within the medical device industry, with a focus on software as a medical device (SaMD).
• In-depth knowledge of relevant standards and regulations, including ISO 13485, FDA 21 CFR Part 11/820, IEC 62304, and ISO 14971.
• Proven experience in preparing and managing regulatory submissions (e.g., FDA 510(k), EU MDR Technical Files).

For more information, please contact Toby Shelton.

Apply now

If you are interested in learning more or applying to this exciting opportunity then please click 'Apply' and upload a copy of your CV. Alternatively for further details or to talk directly to a life sciences recruitment specialist directly please select 'Contact me' at the top of this page.

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

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