Quality & Regulatory Manager

TEC Partners is pleased to have partnered with a prominent boutique consultancy firm in the healthcare sector. Specialising in facilitating the integration of innovative and disruptive solutions into healthcare systems, aiming to secure FDA, CE Mark, or EMA approvals to enhance healthcare delivery and sustainability. Dedicated to guiding healthcare innovations through regulatory processes and strategic planning, leveraging their expertise and industry partnerships to drive successful outcomes for high-growth medical device and biotech companies.

Quality & Regulatory Manager

As the Quality and Regulatory Manager, you will play a pivotal role in ensuring regulatory compliance and maintaining high-quality standards for a range of clients' medical device products. Leveraging your expertise in Software as a Medical Device, you will oversee the compilation of technical files, conduct audits, and implement robust Quality Management Systems (QMS) tailored to SaMD development.

Quality & Regulatory Manager Responsibilities

• Compile technical files and documentation for regulatory submissions, ensuring completeness and accuracy
• Conduct internal and external audits to verify compliance with regulatory requirements and quality standards
• Implement and maintain ISO 13485 Quality Management Systems (QMS) optimized for SaMD development processes
• Stay abreast of regulatory requirements for SaMD products, including FDA, CE Mark, and EMA regulations
• Collaborate closely with internal teams and clients to provide regulatory guidance and ensure alignment with business objectives
• Proactively identify and address regulatory challenges, employing analytical thinking and problem-solving skills to implement effective solutions

Quality & Regulatory Manager Requirements

• STEM degree or equivalent experience with a consultancy
• Strong background in Software as a Medical Device (SaMD) and compliance with IEC 62304 standards
• Experience compiling technical files and documentation for regulatory submissions.
• Proficient in conducting both internal and external audits, ensuring compliance with regulatory requirements
• Proven experience implementing ISO 13485 Quality Management Systems tailored to SaMD development
• Deep understanding of regulatory requirements for SaMD products, including FDA, CE Mark, and EMA regulations
• Excellent collaboration and communication skills to work effectively with internal teams and clients
• Proactive problem-solving and analytical abilities to address regulatory challenges and implement solutions effectively

If you are passionate about driving innovation in healthcare and ensuring regulatory compliance for innovative med dev products, please apply with an up to date CV!