Lead Quality Assurance and Regulatory Affairs Expert
This senior leadership role combines strategic oversight with hands-on execution, requiring regular collaboration with cross-functional teams including engineering, clinical, operations, and external partners.
Key Responsibilities
* Oversight of the Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR, and other relevant standards.
* Leadership of internal and external audits, including regulatory inspections and notified body assessments.
* Risk management activities in accordance with ISO 14971.
* Compliance across design controls, CAPA, supplier quality, and post-market surveillance processes.
* Cultivation of a culture of quality through training, continuous improvement initiatives, and cross-functional collaboration.
Regulatory Strategy
* Development and execution of global regulatory strategies for current and future medical device products.
* Preparation and management of submissions for regulatory approvals (e.g., FDA 510(k), CE Marking under MDR, UKCA, Health Canada).
* Serving as the primary regulatory contact for global authorities and notified bodies.
* Monitoring regulatory changes and proactively updating internal procedures and roadmaps.
* Support for clinical and post-market regulatory activities, including vigilance and complaint handling.
Leadership and Strategy
* Management Representative for quality and regulatory matters.
* Contribution to organizational strategy and high-level decision-making.
* Mentorship and scaling of the QA/RA team to support company growth.
* Collaboration closely with R&D, Clinical, Operations, and Commercial teams to ensure alignment between innovation and compliance.