Job Title: Director of Quality Assurance & Regulatory Affairs
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Description:
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We are seeking a highly experienced senior leadership professional to lead regulatory strategy and quality operations across the entire product lifecycle. This senior leadership position combines strategic oversight with hands-on execution and requires regular collaboration with cross-functional teams including engineering, clinical, operations, and external partners.
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Key Responsibilities:
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* Own, maintain, and continuously improve the Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR, and other relevant standards.
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* Lead internal and external audits, including regulatory inspections and notified body assessments.
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* Oversee risk management activities in accordance with ISO 14971.
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* Ensure compliance across design controls, CAPA, supplier quality, and post-market surveillance processes.
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* Drive a culture of quality through training, continuous improvement initiatives, and cross-functional collaboration.
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* Develop and execute global regulatory strategies for current and future medical device products.
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* Prepare and manage submissions for regulatory approvals (e.g., FDA 510(k), CE Marking under MDR, UKCA, Health Canada).
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* Serve as the primary regulatory contact for global authorities and notified bodies.
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* Monitor regulatory changes and proactively update internal procedures and roadmaps.
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* Support clinical and post-market regulatory activities, including vigilance and complaint handling.
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Leadership & Strategy:
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Serve as the Management Representative for quality and regulatory matters. Contribute to organizational strategy and high-level decision-making. Mentor and scale the QA/RA team to support company growth. Collaborate closely with R&D, Clinical, Operations, and Commercial teams to ensure alignment between innovation and compliance.
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Qualifications & Experience:
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A Bachelor's or Master's degree in Engineering, Life Sciences, Quality, Regulatory, or related discipline is essential. 8-12+ years of experience in Quality and Regulatory roles within the medical device industry is preferred. Proven expertise with ISO 13485, FDA QSR, EU MDR, and global submission processes is required. Demonstrated ability to build and scale compliant systems in fast-paced or high-growth environments is essential. Strong leadership, project management, and communication skills are necessary.
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Benefits:
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Take a senior leadership role in a company committed to technological and clinical innovation. Collaborate in a high-impact environment with visibility at the executive level. Enjoy flexibility, autonomy, and opportunities for professional growth. Competitive compensation and benefits offered.
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About Us:
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We specialise in sourcing professionals for key industries and services.
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Skills:
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Quality Management, Audits, Regulatory, Quality Assurance, Quality Control